Fluid delivery system and related methods of use

ABSTRACT

An apparatus and method for ejecting fluid from a fluid delivery system. The fluid delivery system has a pneumatic assembly that when triggered injects gas into a hydraulic assembly, which in turn ejects fluid through an external interface. An electronic interface displays various measurements, for example, how much fluid has been ejected and if the hydraulic system is closed the pressure of the system. The pneumatic assembly can also be depressurized such that fluid can reenter the hydraulic assembly through the external interface.

This is a continuation of application Ser. No. 12/623,055, filed Nov.20, 2009 now U.S. Pat. No. 8,147,511 which is a continuation ofapplication Ser. No. 10/439,334 (now U.S. Pat. No. 7,641,668), filed May16, 2003, which are both incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to an apparatus and method for deliveringfluid. In a particular embodiment, the present invention relates to aself-contained, gas-powered, hydraulically-controlled inflation systemthat is hand-held. The system may be used, for example, in connectionwith a medical device, and is especially suitable for use in connectionwith balloon dilatation.

BACKGROUND OF THE INVENTION

Gastrointestinal strictures are abnormal narrowings that have formed inthe gastrointestinal tract. Gastrointestinal strictures come in severalforms, among them benign and malignant strictures in the esophageal,pyloric, and colonic regions of the gastrointestinal tract. Thesestrictures are undesirable because they interfere with the normalingestion and digestion of food through the gastrointestinal tract. Suchabnormal ingestion/digestion is often accompanied by undesirable sideeffects, such as gastric ulcer pain, anorexia, nausea, vomiting,discomfort, and Hematemesis.

Gastrointestinal strictures form for a variety of reasons. For example,benign esophageal strictures may be the result of diseases such aspeptic esophagitis or gastroesophageal reflux. They may also be theresult of congenital conditions, such as the presence of membranousdiaphragms or webs in the esophagus. Additionally, they may be theresult of injury or scarring in the esophagus due to the ingestion oftoxic substances. Malignant strictures, on the other hand, are moreoften the result of gastrointestinal cancer. For example, one specifictype of gastrointestinal cancer called Barrett's esophagus is a resultof chronic gastroesophageal reflux disease (stomach acid continuallyenters the esophagus), and sometimes causes the formation of malignantstrictures in the lower portion of the esophagus.

There are presently two known endoscopic methods of treatinggastrointestinal strictures. The first is through the use of one or morerigid dilatators. In this method, a rigid dilatator of a selected sizeis introduced into the gastrointestinal tract through either the oral orrectal orifice and advanced to the stricture location. Once the rigiddilatator is positioned at the stricture location, it is forced throughthe stricture. Through this application of radial and shearing forcesvia the rigid dilatator, the stricture tears and/or expands. This firstrigid dilatator may then be removed and, if desired, a larger rigiddilatator may then be advanced into the gastrointestinal tract andforced through the stricture. This process may be repeated until thestricture has been sufficiently dilated or altogether eliminated.

One problem associated with this treatment method, however, is that theuse of sheer force sometimes causes trauma to the sensitive tissue inthe gastrointestinal tract. In addition, the size of a rigid dilator islimited by the cross-sectional area of the portions of thegastrointestinal tract leading up to the stricture. Thus, due to thedilatator's size limitation, it may not be possible to expand thestricture beyond a certain size that is short of that particulargastrointestinal tract portion's normal cross-sectional area.

Another known endoscopic method of treating gastrointestinal stricturesis by the use of balloon dilators such as, for example, a wire-guidedballoon dilators or a fixed wire balloon dilators. When using awire-guided balloon dilator, a separate wire is advanced through thegastrointestinal tract to the stricture location. Then, a balloondilator is advanced over the wire to the stricture location. A balloonat the distal end of the dilator is positioned within the stricture andinflated to a desired size. The inflation fluid is passed from aproximal end of the dilator through the dilator catheter to the balloon.A fixed-wire balloon dilator is similar to the wire-guided balloondilator except that the balloon is fixed to the end of the wire. Thus,the entire balloon and wire assembly is advanced together through thegastrointestinal tract to the stricture location, where the balloon isthen expanded by filling it with fluid.

To inflate the balloon of a balloon dilator, the user may attach asyringe-like device to the proximal end of the dilatation catheter, andthen manually inject sufficient fluid into the balloon so that itreaches a desired size. Although such a system can be effective, itincludes a number of steps to prepare the system, may require a certainlevel of manual dexterity and coordination between the user andassistants, and can lead to imprecise inflation of the balloon.

It is accordingly an object of the invention to create a fluid deliverysystem that is easy to use, precise, and effective.

SUMMARY OF THE INVENTION

In accordance with an aspect of the invention, an embodiment of theinvention includes a balloon catheter having a proximal handle assembly.The balloon catheter may include a catheter attached to a handleassembly and configured to receive inflation fluid from the handleassembly, and a balloon attached to the distal end of the catheter andconfigured to receive inflation fluid from the catheter. The handleassembly of the balloon catheter may have a first assembly including anactuator connected to a reservoir for releasing pressurized fluid fromthe reservoir, and a second assembly having an inflation fluid chamber.The second assembly may be connected to the first assembly to receivepressurized fluid from the first assembly and connected to the catheterto deliver inflation fluid to the catheter in response to the receipt ofpressurized fluid.

According to another aspect of the invention, an embodiment of theinvention includes a fluid delivery system for connecting to a ballooncatheter having a balloon. The fluid delivery system may include a firstassembly having an actuator connected to a reservoir for releasingpressurized fluid from the reservoir, and a second assembly having aninflation fluid chamber. The second assembly may be connected to thefirst assembly to receive pressurized fluid from the first assembly and,in response to receipt of the pressurized fluid, deliver inflation fluidfrom the inflation fluid chamber to an external interface configured forconnection to a balloon catheter. The fluid delivery system may alsoinclude an electronic interface to display information relating to ameasurement of the fluid in the second assembly.

According to yet another aspect of the invention, an embodiment of theinvention includes a fluid delivery system for connection to a ballooncatheter having a balloon. The fluid delivery system may include a firstmeans for providing pressurized fluid, a second means in fluidcommunication with the first means for receiving the pressurized fluidand, in response to receipt of the pressurized fluid, deliveringinflation fluid to a balloon catheter. The fluid delivery system mayalso include a third means operably connected to the second means formeasuring inflation fluid pressure in the second means and a fourthmeans for receiving an inflation fluid pressure measurement from thethird means and displaying information relating to the inflation fluidpressure measurement.

According to still another aspect of the invention, an embodiment of theinvention includes a method of delivering inflation fluid to a balloonof a balloon catheter. The method may include actuating an actuator toincrease pressure, the increase in pressure forcing fluid to a balloonto increase a size of the balloon, measuring the pressure, deriving aballoon size from the measured pressure, and monitoring the balloon sizeon an electronic interface.

According to another aspect of the invention, an embodiment of theinvention includes a method of dilating a stricture. The method mayinclude advancing a balloon of a balloon catheter to a stricturelocation, actuating an actuator of a handle of the balloon catheter toincrease a pressure in an inflation fluid chamber and force fluid to theballoon to increase a size of the balloon, measuring the pressure,electronically deriving the size of the balloon from the measuredpressure, and monitoring the size of the balloon.

According to yet another aspect of the invention, an embodiment of theinvention includes a method of dilating a stricture. The method mayinclude advancing a balloon of a balloon catheter to a stricturelocation, actuating an actuator of a handle of the balloon catheter toincrease a pressure in an inflation fluid chamber and force fluid to theballoon to increase a size of the balloon, measuring the pressure, andelectronically displaying information based on the measured pressure.

According to still another aspect of the invention, an embodiment of theinvention includes a fluid delivery system. The fluid delivery systemmay include an actuator connected to a valve for releasing a firstpressurized fluid and an assembly defining a fluid chamber forcontaining a second fluid and having a volume that changes in responseto the release of the first pressurized fluid. The fluid delivery systemmay also include an external interface in fluid communication with thefluid chamber, a sensor operably connected to the assembly to takemeasurements from the fluid chamber, and an electronic interfaceconnected to the sensor to determine information relating to themeasurements taken by the sensor.

According to another aspect of the invention, an embodiment of theinvention includes a method of delivering fluid. The method may comprisereleasing a pressurized fluid to decrease a volume of a chambercontaining a delivery fluid, dispensing the delivery fluid from thechamber due to the decrease in volume of the chamber, takingmeasurements of at least one of pressurized fluid pressure, deliveryfluid pressure, and the amount of delivery fluid dispensed, anddisplaying information relating to the measurements.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims. Both the foregoing general description and thefollowing detailed description are exemplary and explanatory only andare not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1 is a perspective view of an integral fluid delivery system andballoon dilator, according to an embodiment of the present invention.

FIG. 2 is a perspective view of the inner portions of the fluid deliverysystem of FIG. 1.

FIG. 3 a is a perspective view of the inner portions of a right housingof the fluid delivery system of FIG. 1.

FIG. 3 b is a schematic view of the inner portions of a left housing ofthe fluid delivery system of FIG. 1.

FIG. 4 a is a perspective view of the electronic interface of the fluiddelivery system of FIG. 1.

FIG. 4 b is a schematic view of portions of the electronic interface ofFIG. 4 a.

FIG. 4 c is a perspective view of inner portions of the electronicinterface of FIG. 4 a.

FIG. 4 d-4 e are schematic views of other inner portions of theelectronic interface of FIG. 4 a.

FIG. 5 a is a perspective exploded view of various parts that comprise ahydraulic assembly of the fluid delivery system of FIG. 1.

FIG. 5 b is a perspective of a hydraulic stem of the hydraulic assemblyof FIG. 5 a.

FIG. 5 c is a cross-sectional view of a hydraulic stem of the hydraulicassembly of FIG. 5 b.

FIG. 5 d is a perspective view of a pressure sensor subassembly of thehydraulic assembly of FIG. 5 a.

FIG. 5 e is an end view of a primary piston of the hydraulic assembly ofFIG. 5 a.

FIG. 5 f is a cross-sectional view along line A-A of FIG. 5 e.

FIGS. 5 g-5 i are front, side, and cross-sectional views respectively ofthe hydraulic cap of FIG. 5 a.

FIG. 5 j is a perspective view of an expansion piston of the hydraulicassembly of FIG. 5 a.

FIG. 5 k is a cross-sectional view of the expansion piston of FIG. 5 j.

FIGS. 5 l-m are perspective views of a check valve of the hydraulicassembly of FIG. 5 a.

FIG. 5 n is a perspective view of a hydraulic cylinder of the hydraulicassembly of FIG. 5 a.

FIG. 5 o is a cross-sectional view of a hydraulic cylinder of thehydraulic assembly of FIG. 5 n.

FIG. 6 a is a perspective view of a portion of a pneumatic assembly ofthe fluid delivery system of FIG. 1.

FIG. 6 b is a perspective view of a pneumatic valve of the pneumaticassembly of FIG. 6 a.

FIG. 6 c is a cross-sectional view of the pneumatic valve of FIG. 6 b.

FIG. 6 d is a cross-sectional view of the pneumatic valve of FIG. 6 b.

FIG. 6 e is a perspective view of a lever for use with the pneumaticassembly of FIG. 6 a.

FIG. 7 a is a perspective view of a fluid delivery system having asword-like configuration, according to an embodiment of the presentinvention.

FIG. 7 b is a perspective view of another fluid delivery system having ajoystick-type configuration, according to an embodiment of the presentinvention.

FIG. 7 c is a perspective view of yet another fluid delivery systemhaving a gun-like configuration, according to an embodiment of thepresent invention.

FIG. 7 d is a perspective view of another fluid delivery system having adifferent joystick-type configuration, according to an embodiment of thepresent invention.

FIGS. 7 e-f are perspective views of additional fluid delivery systems,according to various embodiments of the present invention.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention illustrated in the accompanying drawings. Wherever possible,the same reference numbers will be used throughout the drawings to referto the same or like parts.

In the various embodiments, the invention pertains to a device forautomatically delivering fluid. In the various embodiments and thespecification, the use of the term “fluid” should be understood toinclude both liquid and gas. In the embodiments, a user may grip ahandle portion of the device and trigger an actuator on the device whichinitiates fluid delivery from the device. Fluid delivery may bemonitored through, for example, pressure measurements. The monitoringmay be automatic, electronic, and/or displayed to the user. At a desiredmoment based, for example, on the pressure measurement, any othermeasured value, parameters based on a measured value, and/or comparisonsto predetermined amounts, the device either manually or automaticallystops the delivery of fluid. The user again may trigger the actuator onthe device and have the fluid delivery portion of the process repeated,or the user may trigger a deflation portion and at least temporarilydisable the device from being able to deliver fluid.

In some exemplary embodiments, the invention pertains to a device forautomatically inflating a balloon dilator. In embodiments, a user maygrip a handle portion of the device, trigger an actuator on the devicewhich initiates fluid delivery to a balloon of a balloon dilator andinflates the balloon. The size of the balloon may be monitored through,for example, pressure measurements. The monitoring may be automaticallyperformed by the device, preferably electronically, and displayed to theuser. At a desired moment based, for example, on the pressuremeasurement, the balloon size, comparisons to predetermined pressures orsizes, or any other suitable parameter, the device either manually orautomatically stops the delivery of fluid to the balloon. The user mayleave the balloon inflated for a suitable amount of time, again triggerthe actuator on the device to inflate the balloon further to anotherdesired size, or trigger a deflation portion of the device to deflatethe balloon.

FIGS. 1-2 show an exemplary embodiment of a fluid delivery system 10. Asits main components, system 10 includes a housing 20 that contains anelectronic interface 40, a hydraulic assembly 100, a pneumatic assembly60, and an external interface 101. We will describe each such componentin turn.

FIGS. 3 a-3 b show the interior of the housing 20 of an exemplaryembodiment. The housing 20 may be comprised of a right housing portion21, shown in FIG. 3 a, that mates with and is connected to a lefthousing portion 22, shown in FIG. 3 b.

Distributed about the interior of the housing portions 21, 22 may be aplurality of connectors. In this exemplary embodiment, the connectorsinclude protruding connectors 27 b and receiving connectors 27 a. Thus,the right housing portion 21 may be mated to the left housing portion 22by fitting the protruding connectors 27 b on either housing portion 21,22 into their corresponding receiving connectors on the opposite housingportion 21, 22. No particular arrangement of connectors 27 along theinterior of the housing portions 21, 22 is necessary, however, adistribution of connectors 27 throughout the interior of the housingportions 21, 22 may facilitate a more solid mating of the housingportions 21, 22. In one exemplary embodiment, the connectors may beconfigured so that the protruding connectors 27 b are press fit intotheir corresponding receiving connectors 27 a so as to facilitate a moresolid mating between the housing portions 21,22.

The housing portions 21, 22 may have various areas for receiving and/oraccommodating other portions of the fluid delivery system 10. In thisexemplary embodiment, at the distal end 11 of the housing 20 may be anexternal interface notch 23 located proximate to a hydraulic assemblyarea 24 which may be located next to a trigger area 29. The trigger area29 may extend from a pneumatic assembly area 26, which in turn may beproximate to a gas cartridge area 30 and a deflation area 31 near theproximal end of housing 20. Also closer to the proximal end 12 of thefluid delivery system 10 may be a handle portion 28 of the housing 20.The handle portion 28 may be have a soft grip insert molded into it. Atthe bottom of the handle portion 28, on the opposite side of the gascartridge area 30 from the pneumatic assembly area 26, may be areceiving connector 27 a which also serves as a lever connector 32. Ontop of the housing 20, located above the hydraulic cylinder area 24 andpneumatic assembly area 26, housing 20 defines an electronic interfaceopening 25.

Distributed throughout the housing portions 21, 22 may be structuralsupports or rib portions 33. These structural supports 33 may strengthenthe housing 20, facilitate the production of the housing 20 by injectingmolding or some other suitable production method known in the art,and/or serve as dividers for various areas in the housing portions. Forexample, the structural support 33 a located at the distal end of thehousing portions 21, 22 may separate the external interface notch 23 andits adjoining areas from the hydraulic assembly area 24, perhaps evenproviding a fluid tight and/or hermetical seal.

When housing portions 21, 22 are mated to enclose and/or include thevarious other components on the fluid delivery system 10, the system hasa gun-like shape with a handle 28 to be held by a user. The inflationtrigger 61 and deflation button 62 (to be described below) respectivelyaccept the fore-finger and thumb of the user, with the remaining fingersof one user hand resting on the lever 64 (also to be described below).When system 10 is held in this way, the user can easily view electronicinterface 40 and operate system 10.

The housing 20 may have various other alternative configurations. Forexample, the housing 20 is not limited to having two opposing portions,but may be made up of any number of housing portions configured andconnected in any number of ways. Each housing portion may be formed by avariety of methods, for example, by injection molding of plastic orother suitable material. Various other configurations of features withinthe housing 20 and/or housing portions 21, 22 with respect to each othermay also be desirable.

FIGS. 4 a-4 e depict an electronic interface 40 of an exemplaryembodiment. Interface 40 sits within the electronic interface opening 25defined by housing 20. As shown in these Figs., electronic interface 40includes a housing 53 that contains an electronic interface frame 55(FIG. 4 c), an electronic interface board 54 (FIGS. 4 d-4 e), andoperational buttons 51, 52 (FIG. 4 a-4 b). The housing 53 also defines adisplay portion 41 at the top and permits view of a plurality of lights49 which may have corresponding light covers 59. Labels or othersuitable graphics may be placed on the top of electronic interface 40.

Interface board 54 lies toward the bottom of housing 53. On a bottomside of the electronic interface board 54, as depicted, for example, inFIG. 4 c, may be a plurality of circuit connectors for connection toother portions of the fluid delivery system 10. The circuit connectorsinclude a programming test header 46, a deflate switch header 45, apressure sensor header 44, and a power header 43. In variousembodiments, the programming test header 46 may be connected to thedisplay 41, the deflate switch header 45 may be connected to the deflatebutton 62 or the rapid depressurization valve, the pressure sensorheader 44 may be connected to the pressure sensor subassembly 116, andthe power header 43 may be connected to an external or internal powersupply. On that same side of the electronic interface board 54 may alsobe a battery pack assembly 47 and an audio beeper 48. The electronicinterface 40, and therefore its housing 53 and interface board 54, maybe configured to use and/or facilitate the disposal and/or replacementof a battery in the battery pack assembly 47. The interconnection of theelectrical components and their connection to sensors or othercomponents within system 10 may be according to any suitable methodknown in the art.

On the other, top side of the electronic interface board 54 (as shown inFIG. 4 e) may be a plurality of lights 49, 50. The lights 49 may belight emitting diodes (LED) or any other suitable form of illumination.As depicted in the exemplary embodiment of FIG. 4 d, there may beseveral groups of lights. One group of lights 49 a may be indicateballoon inflation pressure and/or size. Using the embodiment where thefluid delivery system connects to a balloon dilatation catheter as adistal assembly, these lights 49 a may indicate when the pressure in theballoon has reached a certain level, or when the balloon has reached acertain size. There may be three of these lights 49 a-1, 49 a-2, 49 a-3,each corresponding to a different level of pressure or size that theballoon has reached. When used with other types of distal assemblies,lights 49 a may indicate other suitable measures.

Another group of lights 49 b may be directional indicator lights. Again,using the example of a balloon dilatation catheter as the distalassembly, lights 49 b may indicate whether the balloon is increasing inpressure/size or decreasing in pressure/size. For example, theillumination of directional indicator light 49 b-1 may indicate thepressure/size of the balloon is decreasing, while the illumination ofdirectional indicator light 49 b-2 may indicate the pressure/size of theballoon is increasing. All of the indicators 49, 50 may have variouscolors to indicate, for example, various pressures or errors.

Still another group of lights 49 c may be error indicator lights. Onceagain using the embodiment with a balloon dilatation catheter, if theballoon is not inflating properly, the electronic interface 40 is notreceiving signals properly, or any other error mode is detected, theerror indicator light 49 c may illuminate. Some other contemplatederrors where lights 49 c, or other error warnings on the electronicinterface 40, may give an indication include leakage from either thehydraulic assembly 100 or pneumatic assembly 60, a sticky piston (i.e.primary piston 105 or the expansion piston 111) or valve, when thepressure readings are above or below a predetermined level, or when thebattery is getting low.

It is also contemplated that substantially simultaneously with whencertain indicator lights 49 are activated, the electronic interface maysend signals to other parts of the fluid delivery system 10 to performcertain functions. For example, when a light 49 a illuminates toindicate a certain balloon pressure/size, the electronic interface 40may send a signal to the pneumatic assembly 60 to cease increasing gaspressure. Similarly, when the error light 49 c illuminates, theelectronic interface 40 may send a signal to the system to either shutdown, or signal the rapid depressurization valve to rapidly depressurizethe entire fluid delivery system 10.

The electronic interface board 54 may also have a backlight 50 thatforms a part of the electronic display 41. This backlight 50 may be aliquid crystal display (LCD) showing text or other visual output itself,or it may illuminate the background of a text display so that the textcan be more easily read.

Sandwiched in between the electronic interface housing 53 and theelectronic interface board 54 may be an electronic interface frame 55.As depicted in the exemplary embodiment of FIG. 4 b, this frame 55 mayhave a plurality of light covers 59, each corresponding to a light 49 onthe electronic interface board. For example, the frame may havepressure/size indicator light covers 59 a-1, 59 a-2, 59 a-3,corresponding respectively to pressure/size indicator lights 49 a-1, 49a-2, 49 a-3. The frame 55 may also have directional indicator lightcovers 59 b-1, 59 b-2 corresponding to directional indicator lights 49b-1, 49 b-2. The frame may additionally have an error indicator lightcover 59 c corresponding to error indicator light 49 c. The frame mayalso have a circuit holder lens 42. This circuit holder lens 42 may be aliquid crystal display (LCD) showing text or other visual output itself,or may be a screen that facilitates viewing of (and may also protect)the visual output on an electronic display 41, such as a cover. Frame 55interconnects light covers 59 and the circuit lens holder 42.

In various embodiments, the display 41 may display, for example, gaspressure readings, fluid pressure readings, balloon size readings (forexample, diameter and/or volume of the balloon) in the case of a balloondilatation catheter, amount of fluid dispensed, amount of fluid in thefluid delivery system, whether any of the readings are changing, errorindications, timer readings (for example, in the case a balloondilatation catheter, how long the balloon has been inflated at atreatment site in the body), temperature readings, whether any of thereadings have reached a predetermined value, bar graphs that correspondto the readings, a power on indication, or any other desired measurementor reading depending on the particular application.

In an exemplary embodiment, the buttons 51, 52 may respectively be amute button 51 and a power button 52. The mute button 51 may be forsilencing the audio beeper 48, for example, when the indicators 49 alight up when they reach a certain level or when the error indicator 49c is illuminated. The power button 52 may be for powering up theelectronic interface 40, for example, prior to the use of the device.

The electronic interface 40 may have various alternative configurations.For example, the electronic interface 40 may not be integral with thetop of housing 20 and instead may be integral with another portion orside of housing 20. In another embodiment, interface 40 may not beintegral with housing 20 at all, instead being connected to housing 20by other means.

In another example, the various electrical components that make up theelectronic interface 40 may be individually distributed throughout thehousing. In yet another example, the electronics housing portion 53 maybe a plurality of electronics housing portions. Different configurationsof the components on the electronic interface board 54 are alsocontemplated. In addition, the components may be arranged on multiplecircuit boards and/or not on circuit boards and joined, for example,through wire connections. In still another example, the light covers 59and circuit lens holder 42 may be configured together into varioussubcomponents, or may be individual pieces either sandwiched between theelectronic interface housing 53 and electronic interface board 55 ordistributed throughout the electronic interface 40.

In addition, the features for display on display 41 or other portions ofthe electronic interface 40 are exemplary and any other featuresconsistent with the use of the fluid delivery system 10 may also bedisplayed. For example, one of the buttons 51, 52 may be for initiatinga timer displayed on the display, or the electronic interface may havemore buttons 51, 52 to perform other functions. In another embodiment,in addition to or as an alternative to buttons 51, 52, command inputscould be by voice command, by a footswitch, or by software on anassociated computer interface. In addition, the output may also bysoftware associated on a computer interface, or by mechanical instead ofelectrical components, for example, gages and poppets. In a furtherembodiment, the electronic interface 40 may function until one of thereadings reaches a predetermined value, cease functioning in that allthe outputs on the electronic interface (i.e. display 41, indicators 49,50) remain fixed, and remain fixed until a restart command, for examplea further actuation of the pneumatic valve, is given. The electronicdisplay 40 could also send or receive data via telemetry.

FIGS. 5 a-5 o show the hydraulic assembly 100 and its components of anexemplary embodiment. In an exemplary embodiment, the hydraulic assembly100 may be configured to contain 30 cubic centimeters of fluid, forexample, to be capable of inflating a balloon of a balloon dilatationcatheter. Other size assemblies are within the scope of the inventionand depend on the particular application and need for fluid. Thehydraulic assembly 100, portions of the hydraulic assembly 100containing fluid, or other fluid containers may be termed reservoirs.

Beginning at the distal end of the hydraulic assembly 100 and withspecific reference to FIG. 5 a, the hydraulic stem 103 connects to thefluid connector 67 on the pneumatic assembly 60 (to be described below).The hydraulic stem 103 then connects to the hydraulic cylinder 102,which contains the primary piston 105. The primary piston 105 thenconnects to or is at feast in contact with a primary piston spring 113.The primary piston spring 113 connects to or is at least in contact withthe hydraulic cap 104. The hydraulic cap 104 in turn connects to or isat least immobilized relative to the hydraulic cylinder 102. Connectedto the hydraulic cap 104 may be a check valve 115 and at least one luerhub 108 which may connect to external interface 101. The hydraulic cap104 may also contain an expansion piston 106. The expansion piston 106connects to or is at least be in contact with an expansion piston spring114, which at an opposite end connects to or is at least in contact witha spring retainer 107.

An exemplary embodiment of the hydraulic stem 103 is depicted in FIGS. 5b-5 c. The hydraulic stem 103 may comprise a pneumatic interface 119that connects to the fluid connector 67 of the pneumatic assembly, ahydraulic cylinder interface 120 that connects to the hydraulic cylinder102, and a hydraulic stem shaft 118 that connects the pneumaticinterface 119 to the hydraulic cylinder interface 120. In the exemplaryembodiment, the central axes of the interfaces 119, 120 areperpendicular to each other and the shaft 118 is linear. It iscontemplated that the pneumatic interface 119 and the fluid connector 67may move axially with respect to each other so as to better facilitate,for example, ease of use, ease of connection, and/or freedom ofmovement.

The junction/interface between the hydraulic stem 103 and the pneumaticvalve 70 through the pneumatic interface 119 and the fluid connector 67may include a hydraulic stem O-ring 110 to facilitate a fluid tightand/or hermetical seal between the two members, and also to prevent thebuildup of gas pressure from destroying the junction/interface. Toreceive the hydraulic stem O-ring 110, the inner surface of thepneumatic interface 119 may be chamfered. The hydraulic stem O-ring 110may also facilitate better axial movement between the pneumaticinterface and the fluid connector while still maintaining the fluidtight and/or hermetical seal.

The interface between the hydraulic cylinder interface 120 and hydraulicstem interface 121 of the hydraulic cylinder 102 may also have an O-ringto facilitate the creation of a fluid tight and/or hermetical seal andalso to prevent the buildup of gas pressure from destroying thejunction/interface. In the exemplary embodiment, the pneumatic interface119 may have a configuration or shape to receive the fluid connector 67,and the hydraulic stem interface 121 may have a configuration to receivethe hydraulic cylinder interface 120.

An exemplary embodiment of the hydraulic cylinder 102 is depicted inFIGS. 5 n-5 o. Hydraulic cylinder 102 may have a fluid chamber 127bounded by a proximal wall 122, at least one sidewall 124, and a distalopening 123. The hydraulic stem interface 121 may be connected to orintegral with the proximal wall 122, and may be in fluid communicationwith the fluid chamber 127. The sidewall 124 may also have locking parts126 located adjacent to the distal opening 123 of the hydraulic cylinder102. The locking parts 126 may be configured to receive a correspondinglocking part 157, for example, disposed on the hydraulic cap 104. Theinner surface 125 of the sidewall 124 may be smooth or otherwiseconfigured to facilitate the movement of members within the hydrauliccylinder 102, for example, the primary piston 105 or the primary pistonO-rings 112. The hydraulic cylinder 102 may be made of a material thatcan withstand high internal/external fluid and/or gas pressures.

An exemplary embodiment of the primary piston 105 is depicted in FIGS. 5e-5 f. The primary piston 105 has a fluid chamber 136 which is in fluidconnection with at least a part of the fluid chamber 127 of thehydraulic cylinder 102. The fluid chamber 136 is bounded by a proximalwall 134, at least one side wall 133, and a distal opening 135. Theinner surface 137 of the primary piston 105 may define at least onespring receiver surface 130 and a hydraulic cap receiver surface 131.The spring receiver surface 130 may be configured to receive or at leastcontact a portion of the primary piston spring 113, and may also beconfigured to be sturdy enough so that force of the primary pistonspring 113 does not substantially deform or break the primary piston.The hydraulic cap receiver surface 131 may also be configured so thatwhen the primary piston spring 113 reaches its maximum point of collapseor compression, the proximal end 140 of the hydraulic cap 104 may besubstantially flush with the hydraulic cap receiver surface 131.

The primary piston 105 may have a plurality of primary piston O-rings112 wrapped around its outer surface 132 to facilitate both a fluidtight and/or hermetical seal with the inner surface 125 of the hydrauliccylinder 102, but also may serve as a friction reducing body so as toallow the primary piston 105 to slide relatively freely and easilywithin the hydraulic cylinder 102. On the outer surface 138 of theprimary piston 105 may be at least one O-ring receiver or groove 132.These O-ring receivers 132 may receive at least one primary pistonO-ring 112.

An exemplary embodiment of the hydraulic cap 104 is depicted in FIGS. 5g-5 i. Hydraulic cap 104 may have a proximal end 140 defining a proximalopening 141. The proximal opening 141 may allow at least portions of aninner chamber 153 of the hydraulic cap 104 to be in fluid communicationwith at least a portion of the fluid chamber 127 of the hydrauliccylinder 102. The proximal end 140 may be connected to proximal sidewall142, which may in turn be connected to the central portion 154 of thehydraulic cap 104. The inner chamber 153 may be bounded by the proximalopening 141, the inner surfaces 150 of proximal sidewall 142, thecentral portion 154, distal protrusions 143, a distal opening 158, anddistal gaps 159 between the distal protrusions 143.

The central portion 154 of the hydraulic cap 104 has many features. Forexample, the central portion 154 may have a check valve connector 144,which may have on one end a proximal opening 145 in fluid communicationwith at least a portion of the fluid chamber 127 of the hydrauliccylinder 102, and on the other end a distal opening 146 configured to beconnected to and/or be in fluid communication with a check valve 115.

The central portion 154 also may have an external interface connector147. The external interface connector 147 may have on one end a proximalopening 148 in fluid communication with at least a portion of the fluidchamber 127 of the hydraulic cylinder 102, and on the other end a distalopening 149 configured to be connected to and/or be in fluidcommunication with the external interface 101. In the alternative, theexternal interface connector 147 may be configured to connect to orreceive at least one luer hub 108, with the luer hubs 108 in turnconnecting with the external interface 101.

Also disposed on the central portion 154 of the hydraulic cap 104 may bea pressure sensor port 152, which may be configured to receive apressure sensor subassembly 116. A hydraulic cap O-ring 117 may bewrapped around a portion, for example the central portion 154, of thehydraulic cap 104 so as to facilitate an air-tight seal between thehydraulic cap 104 and the inner surface 125 of the of hydraulic cylinder102. The central portion 154 may also have at least one O-ring receiveror groove 151 to facilitate receipt and retention of the hydraulic capO-ring 117.

The proximal sidewall 142, central portion 154, and distal protrusions143 may all be connected and, for example, be formed as a single piece.The distal protrusions 143, as depicted in the exemplary embodimentshown in FIGS. 5 g-5 i, are about one-half the length of the hydrauliccap 104 and cover roughly one-half of the circumference of the hydrauliccap, with each individual distal protrusion 143 covering about one-sixthof the circumference and being equally spaced from each other. Thedistal protrusions 143 may be configured to retain, for example, anexpansion piston 106 within the inner chamber 153 adjacent to theprotrusions 143. The inner surface 150 of the hydraulic cap 104 may runalmost the entire length of the hydraulic cap 104, so that it canaccommodate, for example, the movement of an expansion piston 106 alongalmost the entire length of the hydraulic cap 104, for example, from theproximal opening 141 on the proximal end 140 to the distal opening 158.

The hydraulic cap 104 may also have a locking part 157 configured tolock with, for example, the locking part 126 on the hydraulic cylinder102. In an exemplary embodiment, the hydraulic cap 104 and hydrauliccylinder 102 are locked together and form a fluid tight and/orhermetical seal such that no fluid escapes from the fluid chamber 127through a potential gap in the distal opening 123 between the hydrauliccap 104 and the hydraulic cylinder 102. The locking parts 126, 157 mayalso be configured to keep the hydraulic cylinder 102 and hydraulic cap104 together under internal/external gas and/or fluid pressures.

FIGS. 5 j-5 k depict an exemplary embodiment of the expansion piston106. The expansion piston 106 may have a inner chamber 163 that isbounded by a proximal wall 161, sidewalls 162, and a distal opening 167.Adjacent to the junction of the proximal wall 161 and sidewall 162 maybe an O-ring receiver or groove 164 for accommodating the expansionpiston O-ring 111. The expansion piston O-ring 111 may facilitate bothan air-tight seal between the expansion piston 106 and the hydraulic cap104, as well as reducing friction with the inner surface of thehydraulic cap 104. On the portion of the sidewall 162 opposite theO-ring receiver 164, and adjacent to the distal opening 167, may be aspring receiver or groove 165 configured to accommodate the receipt andretention of an expansion piston spring 114. Located between the springreceiver 165 and O-ring receiver 164 along the sidewall 162 may be acentral groove 168. This central groove 168 may be configured to receiveand/or retain an additional expansion piston O-ring, and/or may serveany other suitable function. At the proximal end of the inner chamber163 along the proximal wall 161, and adjacent to the sidewall 162, maybe a chamfered proximal end 166, which may be configured to receive theproximal end of a spring retainer 107, should the expansion pistonspring 114 reach its maximum desired compression.

FIGS. 5 l-5 m depict an exemplary embodiment of the check valve 115 thatmay be connected to the check valve connector 144 on the hydraulic cap104. The check valve 115 may have a hydraulic cap interface 175 whichmay be configured to be inserted into the distal opening 146 on thecheck valve connector 144. To accommodate the check valve 115, the checkvalve connector 144 may have a recess 155 configured to receive theproximal end of the hydraulic cap interface 175 and prevent furtherinsertion of the hydraulic cap interface 175 into the hydraulic cap 104.

The hydraulic cap interface 175 may be connected to the valve chamber177 of the check valve 115 through a flexible interface extension 176,so that the axes of the hydraulic cap interface 175 and valve chamber177, respectively, are not coaxial, and may instead be oriented indifferent directions. The hydraulic cap interface 175 may also beconfigured to withstand pressure from the hydraulic cap 104 to be blownoff when the fluid pressure builds in the fluid chamber 127.

On the side of the valve chamber 177 opposite the hydraulic capinterface 175 may be a valve cap 180 which may include an externalinterface portion 178, which in turn may have an external interfaceopening 179 which leads into the valve chamber 177. The interior of thevalve chamber 177 may be configured to at least initially maintain afluid tight and/or hermetical seal, and even if pressure is exerted fromthe hydraulic cap interface 175 side of the valve chamber 177, the checkvalve 115 could still maintain its seal. However, if pressure is exertedfrom the external interface 178 through the valve cap 180 into the valvechamber 177, the interior of the valve chamber 177 may be configured toaccept fluid flow (for example, fluid for the balloon dilator) from theexternal interface 178, through the valve chamber 177, through thehydraulic cap interface 175, and into the valve chamber 177.Additionally, the interior of the valve chamber 177 may also beconfigured so that if a user wished to eliminate the fluid tight and/orhermetical seal, and allow fluid to flow in the direction from thehydraulic cap interface 175 through the valve chamber 177, the usercould, for example, remove the valve cap 180, or introduce a foreignobject into the external interface opening 179 and dislodge and/orpuncture the portion of the check valve 115 that is configured tomaintain the fluid tight and/or hermetical seal.

FIG. 5 d depicts an exemplary embodiment of the pressure sensorsubassembly 116. The pressure sensor subassembly 116 has a hydraulic capinterface 185 which may be connected to the hydraulic cap 104, forexample, by placing hydraulic cap interface 185 into the pressure sensorport 152. The hydraulic cap interface 185 of the pressure sensorsubassembly 116 may form a fluid tight and/or hermetical seal with thepressure sensor port 152 so as to facilitate the accurate measurement ofthe fluid pressure within the hydraulic cylinder 102. The pressuresensor subassembly may also have an electronics housing 186 which hascircuits or other means for measuring the fluid pressure within thehydraulic cylinder 102, and the electronics housing 186 may also havemeans to relay information, pressure or otherwise, to electronicinterface 40, for example, for display or use in triggering otherfunctions of the system 10. The hydraulic cap interface 185 may also beconfigured to withstand being blown out of the pressure sensor port 152due to pressure increases in the fluid chamber 127, or in anotherembodiment, from gas pressure.

The hydraulic assembly may have various alternate configurations. Anyhydraulic assembly that accepts a gas pressure input, and in response tothat gas pressure input, outputs fluid from the hydraulic assembly maybe acceptable. In addition, no specific fluid capacity of the hydraulicassembly is required or necessary, as the fluid capacity depends on theparticular application.

As additional examples of modifications of the hydraulic assembly, thecentral axes of the interfaces 119, 120 of the hydraulic stem 103 maynot be perpendicular to each other and the shaft 118 may not be linear.In addition, the fluid connector 67 on the pneumatic valve 70 may bedirectly connected to the hydraulic stem interface 121 of the hydrauliccylinder 120, possibly with an O-ring in between. Furthermore, thehydraulic assembly 100 and/or pneumatic assembly 60 may have a internalnozzles to concentrate fluids in various portions of the system. In anadditional example, the hydraulic cylinder could be a collapsible sac102 that may be configured to rebound as well, for example, through theutilization of elastomeric walls or by building springs into the walls.

In yet another example, the spring receiver 130 of the primary piston105 may be located distally from the hydraulic cap receiver 131 relativeto the proximal wall 134, the spring receiver 130 and hydraulic capreceiver 131 may actually share the same flat surface portion of theinner surface 137. In addition, the primary piston spring 113 and/or thehydraulic cap 104 may be configured so that the hydraulic cap 104 nevercomes into contact with the hydraulic cap receiver 131. Along thoselines, the pistons 105, 111 and fluid reservoirs in the hydraulicassembly 100 could be configured so that the pistons 105, 111, no matterwhat the fluid pressure, are never bounded by portions of the hydraulicassembly 100 so that movement is prevented in either direction. This maybe preferable so that the fluid delivery system 10 could be put ininflation mode or deflation mode at any point in time withoutconsideration of space and movement limitations.

In still another example, the features disposed on the hydraulic cap104, such as the check valve 115 and pressure sensor subassembly 116,may be located on other suitable portions of the hydraulic assembly 100or pneumatic assembly 60. For example, the check valve may be connectedto the hydraulic cylinder 102, the external interface 101, or some othersuitable portion of the hydraulic assembly 100 that, for example, allowsfluid communication with the fluid chamber 127. In another example, thepressure sensor subassembly 116 may be connected to the hydrauliccylinder 102 or the external interface 101, or any other portion of thehydraulic assembly 100 or pneumatic assembly 60 where it can measure,for example, fluid and/or gas pressure. In general, the various portionsof the hydraulic assembly 100 may be spread out in various portions ofthe fluid delivery system 10, and may be connected by hydraulic lines.

In another example, the expansion piston 106 and expansion piston spring114 assembly may in fact be any system configured to store potentialenergy during the ejection of fluid from the fluid delivery system 10,and release energy following the end of the ejection of the fluid fromthe fluid delivery system 10. The expansion piston 106 may also be madeof a compressible material, for example, so as to completely fill thecross-sectional area of the inner chamber 153 of the hydraulic cap 104,or to give additional compression to the system so as to store morepotential energy.

FIGS. 6 a-6 e depict portions of an exemplary embodiment of thepneumatic assembly 60. The pneumatic assembly 60 may be located insidethe handle portion 28 of the housing 20. Components of pneumaticassembly 60, shown in FIGS. 1, 2 and 6 a-6 e, include a pneumatic valve70, a deflation button 62, a gas cartridge 63, and a lever 64. Thepneumatic assembly 60 may also comprise a rapid depressurization valve91.

FIGS. 6 a-6 d depict an exemplary embodiment of the pneumatic valve 70.The pneumatic valve 70 may comprise a pneumatic valve base 71 with arelief cap 90, an inflation trigger 61, and a gas cartridge interface 66connected to various portions of the pneumatic base 71. The pneumaticvalve 70 may also have a rapid depressurization valve. Additionally, alever 64 may be simultaneously connected to the inflation trigger 61 andthe lever connector 32 on the housing 20. Furthermore, a gas cartridge63 may be connected, in a fluid tight and/or hermetical manner, to thegas cartridge interface 66.

The relief cap 90 includes a deflation interface 65 that when combinedwith the other parts of the fluid delivery system 10, may connect withor at least contact the deflation button 62. In one exemplaryembodiment, the depression of the deflation button 62 may cause themovement of the deflation interface 65 away from the relief cap 90 whichin turn may cause the relief cap 90 to discharge gas, for example,through a gap in the junction between the deflation interface 65 and therelief cap 90, through a relief gap 187 disposed between a groovedportion 72 of the pneumatic valve 70 and a grooved portion 186 of therelief cap 90, or through some other portion of the relief cap 90. Inthe exemplary embodiment, the relief cap 90 is held onto a relief capportion 488 of the pneumatic valve base 71 by being threaded onto thepneumatic base 71, for example, through the interlocking of the groovedportion 72 of the pneumatic valve 70 and the grooved portion 186 of therelief cap 90. However, in another example, the relief cap 90 may beheld onto the pneumatic valve base 71 by the housing portions 21, 22, orby some other fastening means. The relief cap 90 may also have portionsnear its proximal end 190 configured to retain or at least be in contactwith a relief spring 165. The relief spring 165 may be disposed around,for example, the deflation valve legs 188 of the deflation valve 166,and have one end retained by or at least in contact with a relief springreceiver portion 191 of the deflation valve 166.

In an exemplary embodiment, the relief cap may include the deflationinterface 65 integral with a deflation shaft 160 which may in turn beintegral with a deflation ball interface 163. The deflation ballinterface 163 may have deflation shaft positioners 162 which may keepthe deflation ball interface 163 and the deflation shaft 160 centered inthe relief cap 90 and/or the relief cap interface chamber 76 of thepneumatic valve 70. The deflation shaft positioners 162 may keep thoserelief cap portions centered by virtue of its interaction with thedeflation valves legs 188 which may be connected to the deflation valve166, for example, acting as spring-like elements which may allow, givenexternal pressures, movement of the deflation ball interface 163 anddeflation shaft 160 relative to the pneumatic valve 70. The deflationshaft positioners 162 may be rigid enough so that in the absence ofexternal pressures, it biases the deflation ball interface 163 anddeflation shaft 160 to their original locations. The deflation valvelegs 188 may also have deflation leg receiver 194 that, when moved farenough toward the proximal end 190 of the relief cap 90, may come intocontact with the shaft positioner receivers 193 disposed on thedeflation valve legs 188 and prevent further movement of the deflationshaft 160 and the deflation ball interface 162 toward the proximal end190 of the relief cap 90. The deflation shaft 160 may also have adeflation spring receiver 189 for retaining or at least being in contactwith an end of a deflation spring 161. The deflation spring 161 may bedisposed around the deflation shaft 160 and extend to almost thedeflation interface 65, being retained or at least in contact with aproximal end 190 of the relief cap 90.

The deflation valve 166 may be lodged against a chamfered deflationvalve receiver portion 192 that is disposed in the relief cap interfacechamber 76 of the pneumatic valve 70. The deflation valve O-ring 168 maybe lodged between the deflation valve 166 and the chamfered deflationvalve receiver portion 192 of the pneumatic valve base 71 and mayprovide a fluid tight and/or hermetical seal. The deflation valve 166may have within it a deflation valve passage 167 extending, for example,along a central axis and configured to facilitate fluid communicationbetween the fluid transfer chamber 73 and portions of the relief capinterface chamber 76 disposed between the deflation valve legs 188.Lodged between the proximal end of the deflation valve passage 167 ofthe deflation valve 166 and the deflation ball interface 163 may be adeflation bail 164 which, depending on its position, may facilitate orimpede fluid communication between the between the fluid transferchamber 73 and portions of the relief cap interface chamber 76 disposedbetween the deflation valve legs 188.

In another exemplary embodiment, the relief cap 90, or other portion ofthe pneumatic assembly 60 may comprise a rapid depressurization valveconnected to a rapid depressurization button, where the user may, bypressing the button, rapidly depressurize the pneumatic assembly. Therelief cap 90 may also have high pressure valves 91, for example, aspring activated poppet valve 91, that regulates the maximum pressure inthe pneumatic assembly 60. The poppet valves 91 may be configured tohave a poppet ball lodged in the interface portion of the poppet valve91 which is in fluid communication with the relief cap interface chamber76. The poppet ball may be held against the interface portion of thepoppet valve 91 by a poppet spring. The poppet spring may be calibratedto hold the poppet ball in the interface portion of the poppet valve 91with an appropriate amount of force such that only when the pressure inthe relief cap interface chamber 76 reaches a predetermined maximumlevel will the poppet spring compress, the poppet ball move away fromthe interface portion, and thus the relief cap interface chamber 76 bein fluid communication with the external environment via the poppetvalve 91.

An exemplary embodiment of the pneumatic valve base 71 is depicted inFIGS. 6 b-6 d. The base 71 includes a valve body 84 with a plurality ofchambers within it. For example, the valve body 84 may define a fluidintake chamber 74 configured to be in fluid communication with a triggerinterface chamber 75 through a trigger-controlled passage 85. Thetrigger interface chamber 75 is in fluid communication with a fluidtransfer chamber 73 through an interchamber passage 81, and the fluidtransfer chamber is in fluid communication with a relief cap interfacechamber 76. The fluid connector 67 is in fluid communication with thefluid transfer chamber 73 and also with the hydraulic cylinder 102through the hydraulic stem 103. The pneumatic valve 70 may additionallyhave an external opening 86 and fluid intake chamber 74 configured toconnect to and form a fluid tight and/or hermetical seal with a gascartridge interface 66, which in turn may be configured to connect toand form a fluid tight and/or hermetical seal with a gas cartridge 63.The gas cartridge 63 may also be a reservoir or fluid reservoir.

The fluid transfer chamber 73 may have a plurality of internalstructures, for example, to facilitate interaction with the deflationvalve portion 166 of the relief cap 90, and to also control fluid flowthrough the chamber 73 from the interchamber passage 81. For example,the fluid transfer chamber 73 may have lodged within it a fluid transferball 169 which, due to the force and contact from a fluid transferspring 170, may be lodged in a chamfered portion of the fluid transferchamber 73 that may block fluid communication through the interchamberpassage 81. The end of the fluid transfer spring 170 opposite the fluidtransfer ball 169 may be lodged, for example, up against a portion ofthe deflation valve 166 and may be disposed around a portion of thedeflation valve 166.

The fluid intake chamber 74, trigger controlled passage 85, and triggerinterface chamber 75 may additionally have a plurality of internalstructural elements. For example, the fluid intake chamber 74 may havean external opening 86 on one end and a trigger controlled passage 85 onthe other. The trigger controlled passage 85 may be configured tofacilitate fluid communication between the fluid intake chamber 74 and atrigger interface chamber 75. The trigger interface chamber 75 may haveon one end the trigger controlled passage 85 and on the other end atrigger opening 87. The trigger interface chamber 75 may be configuredto receive a trigger interface 80.

In an exemplary embodiment, the trigger interface 80 may include triggerinterface body 195 that is threaded on at least a part of its interiorand has screwed within it a trigger interface plug 172. The triggerinterface plug 172 may serve as an adjustable needle valve to regulategas flow. The trigger interface body 195 may be configured to interfacewith, on one end, the trigger body 89 of the inflation trigger 61, andon the other end may have a trigger interface shaft 175 which may behollow and have lodged within at least a part of the hollow portion atrigger plug shaft 174. The trigger interface plug 172 may be configuredto have disposed around it an O-ring, for example, to maintain a fluidtight and/or hermetical seal between the trigger interface plug 172 andthe inner portion of the trigger interface body 195. The triggerinterface shaft 175 may be lodged in, for example, the triggercontrolled passage 85 between the trigger interface chamber 75 and thefluid intake chamber 74. The trigger interface shaft 175 may havedisposed around it a trigger controlled passage O-ring 176 which may belodged in a O-ring receiver portion 196 of the trigger controlledpassage 85. The trigger controlled passage O-ring 176 may, for example,provide at times a fluid tight and/or hermetical seal in the triggercontrolled passage 85 between the valve body 84 and the triggerinterface shaft 175, may ensure that the trigger interface shaft 185 iscentered in the trigger controlled passage 85, and may also facilitatemovement of the trigger interface shaft 175 relative to the valve body84 and the trigger controlled passage 85. The trigger interface body 195may also have disposed around it an trigger interface O-ring 171, forexample, near the trigger opening 87 of the trigger interface chamber75. The trigger interface O-ring 171 may facilitate a fluid tight and/orhermetical seal between the trigger interface body 195 and the valvebody 84 around the trigger interface chamber 75, and may also facilitatemovement of the trigger interface 80 relative to the valve body 84.

In another exemplary embodiment, the end of the trigger interface shaft175 opposite the trigger interface body 195 may be in contact, throughthe insertion opening 260 of the gas cartridge interface 66, with a gascartridge interface ball 177 lodged in the gas cartridge interfacechamber 199 of the gas cartridge interface 66. The gas cartridgeinterface 66 may have an insertion portion 198 containing the gascartridge interface ball 177. The gas cartridge interface ball 177 maybe lodged up against a gas cartridge interface ball O-ring 178 which inturn may be disposed up against the insertion portion 198 around theinsertion opening 260. The insertion portion 198 may be lodged in thefluid intake chamber 74 of the pneumatic base 71. A portion of the gascartridge interface ball 177 may be lodged in the insertion opening 260in addition to being in contact with the trigger interface shaft 175. Onthe side of the gas cartridge interface ball 177 opposite the insertionopening 260 may be a gas cartridge interface spring 179. The insertionportion 198 of the gas cartridge interface 66 may be lodged up against aportion of the valve body 84 disposed around the fluid intake chamber74, and specifically may be lodged up against the wall portion 265 ofthe valve body 84 surrounding the trigger controlled passage 85. Theinterface between the insertion portion 198 of the gas cartridgeinterface 66 and the wall portion 265 may be fluid tight and/orhermetically sealed so as to prevent fluid flow from the chamber portion199 of the gas cartridge interface 66 to the outside environmentthrough, for example, the gap on the sides between the insertion portion198 and the valve body 84 as depicted in FIG. 6 d.

The gas cartridge interface spring 179 may, on the side opposite the gascartridge interface ball 177, be up against a gas cartridge interfaceplug 180 which may be lodged in an interior opening 262 that roughlydivides the gas interface cartridge 66 into the insertion portion 198and interface portion 261. The gas cartridge interface plug 180 may havea gas cartridge interface plug passage 181 which may be configured tofacilitate fluid communication between the insertion chamber 199 and thechamber portions 263 of the interface portion 261. The gas cartridgeinterface plug 180 may have a gas cartridge interface end 264 which maybe in contact with a portion of the gas cartridge 63 that, if moved awayfrom the chamber portion 199 of the insertion portion 198, would causegas to flow from the gas cartridge 63 and into the gas cartridgeinterface 66. The gas cartridge interface 66 may also have a gascartridge stopper O-ring 185 that may stop the gas cartridge 63 frombeing inserted further into the gas cartridge interface 66, and may alsocushion the gas cartridge interface plug 180 so as to allow it to beretained substantially in the interior opening 262, even if it is movedslightly away from the chamber portion 199 of the insertion portion 198due to pressure from the gas cartridge interface spring 179. Theinterface portion 261 may also have a gas cartridge receiver O-ring 184lodged in gas cartridge receiver 182, for example, to grip the sides ofa gas cartridge 63 and provide a fluid tight and/or hermetical sealbetween the gas cartridge 63 and the gas cartridge interface 66. Theinterface portion 261 of the gas cartridge interface may have portionsto retain and hold the gas cartridge receiver O-ring 184 and the gascartridge stopper O-ring 185.

The inflation trigger 61 may be connected to the pneumatic valve base 71by a hinge interface 82 which may grip a hinge 68 disposed on thepneumatic valve base 71. The inflation trigger 61 may have a portionconfigured to interact with and/or seal a portion of the pneumatic valve70, and additionally have a trigger interface 83 for actuation by theuser.

At one end, the lever 64, as depicted in FIG. 6 e, includes a leverconnector receiver 291 configured to connect to the lever connector 32of housing 20. At an opposite end, the lever 64 may also have a triggerconnector receiver 92 configured to connect to a trigger connector 93(see FIG. 1), which in turn may be connected to the inflation trigger61. The lever body 94 may be configured to cover at least a portion ofthe gas cartridge 63 that may be lodged within the housing 20. The lever64 may also be configured to be easily removable, for example, bydisconnecting the trigger connector 93 from either the inflation trigger61 or the lever 64, and then rotating the lever 64 away from the gascartridge (using the lever connector 32 as the rotational axis), so thatthe gas cartridge 63 in the housing 20 is now accessible. In anexemplary embodiment, the gas cartridge may be accessible so as tofacilitate disposal and/or replacement of the gas cartridge. Also in anexemplary embodiment, the gas cartridge 63 may be metal, contain CO₂gas, weigh about 12 grams, and operate at an initial pressure of about900 psi.

The pneumatic assembly 60 may have various alternate configurations. Forexample, with regards to the relief cap 90 screwed onto pneumatic base71, any other fluid tight and/or hermetically sealed interfaceconfiguration that can withstand the stress from the internal gaspressure is also acceptable. In another example, various configurationsother than the exemplary embodiment described above are contemplatedthat allow the pneumatic valve 70, when triggered, to flow gas from thegas cartridge interface 66 to the fluid connector 67. For example, thepneumatic valve 70 may only have one chamber and one seal, andtriggering the pneumatic valve 70 may open that one seal. The relief cap90, or other means for depressurizing the pneumatic valve, may also beconnected to that one chamber. Other configurations are alsocontemplated that allow the pneumatic valve 70, when triggered, to stopthe flow of gas from the gas cartridge interface 66 to the fluidconnector 67. In another exemplary embodiment, the inflation trigger 61may be a button, or any other type of interface where the user canmanually actuate the fluid delivery system 10.

In various embodiments, the way in which in the depression or otherwiseinitiation of the inflation trigger 61 causes the actuation ofcomponents in the pneumatic assembly 60 may be varied. For example, theinflation trigger 61 may be mechanically coupled to the pneumaticassembly 60 through the trigger interface 80, and thus the force used todepress the inflation trigger 61 may physically move components of thepneumatic assembly 60. In another example, the inflation trigger 61 maybe electrically coupled to the pneumatic assembly 60 through the triggerinterface 80, and thus the force used to depress the inflation trigger61 may not physically translate into movement of various components inthe pneumatic assembly 60, but instead may send electronic signals tothe pneumatic assembly which in turns may initiate a series of eventsthat may cause the increase in gas pressure within at least parts of thepneumatic assembly 60 and/or hydraulic assembly 100.

It should be understood that with regard to the configuration of thepneumatic assembly 60, any configuration of the gas cartridge 63 andpneumatic assembly 60 that would facilitate fluid flow from the gascartridge 63 to the pneumatic assembly 60 upon actuation of theinflation trigger 61 is acceptable. Additionally, any configuration thatfacilitates fluid flow from the pneumatic assembly 60 to the hydraulicassembly 100 is acceptable. Furthermore, any configuration that stopsgas flow once the cease flow indication is given is acceptable. Inaddition, the various portions of the pneumatic assembly 60 may bespread out in various portions of the fluid delivery system 10, and maybe connected by pneumatic lines.

In an exemplary embodiment shown in FIG. 1, the external interface 101includes a strain relief portion that is integral with a balloon dilator200 as the distal assembly. A catheter 201 extends from the strainrelief portion and is in fluid communication with the external interface101. Catheter 201 leads to a dilation balloon 202 at a distal end of thedilator 200. In an exemplary embodiment, the balloon dilator 200 may befixedly connected to the external interface 101 during the manufacturingprocess. Accordingly, the fluid delivery system 10 may be sold withballoon dilator 200 already attached. This may be desirable if the fluiddelivery system 10 is an inexpensive single use device that isdisposable. In the case that the fluid delivery system 10 may be soldwith the balloon dilator 200 attached via the balloon catheter 201, itmay be preferable to have the balloon dilator 200 and balloon catheter201 completely filled with fluid prior to use, for example, during themanufacturing process. This may be preferable because the presence ofany air in the balloon dilator 200 or balloon catheter 201 may lead toinaccuracies in the system, as air is much more compliant than otherfluids, that may be dangerous to the person. Alternatively, as describedbelow, balloon dilator 200 may be sold separately and configured to bemated with the external interface 101. In addition, it may be preferableto provide the fluid delivery system 10 without fluid, and then fill thehydraulic assembly 100 with fluid at the time of operation to, forexample, prevent leakage.

Commercially available balloon dilators that may be configured to beused in connection with the fluid delivery system 10 include CRE™Wireguided Balloon Dilators and CRE™ Fixed Wire Balloon Dilators sold byBoston Scientific Corporation®. Such dilators include a balloon fixed tothe end of a catheter and inflated by injecting through the catheterfrom a proximal fluid delivery device, for example, a fluid deliverysystem 10. The balloon is configured to be filled to three distinctdiameters at three different fluid pressures. For example, if thepressure of the fluid in the balloon is about three atmospheres, thenthe balloon dilator diameter may be about 10 mm. In another example, ifthe pressure of the fluid in the balloon is about five atmospheres, thenthe balloon diameter may be about 11 mm. In yet another example, if thepressure of the fluid in the balloon is about eight atmospheres, thenthe balloon diameter may be about 12 mm. The CRE™ balloon dilators alsomay have rectilinear shoulders 203 on both ends joined by a centralportion with a roughly uniform diameter along its length, have a highradial dilatation force 204 (i.e., is extremely hard when filled and mayfeel like an incompressible material such as metal or glass), and havean atraumatic tip 205 so as to reduce the trauma on the gastrointestinaltract during insertion.

In another embodiment, the balloon dilator 200 may have a sensor locatedon it, for example, in place of the atraumatic tip 205 as depicted inFIG. 1. The sensor may be configured to sense how the dilation isprogressing, for example, whether the gastrointestinal stricture hasbeen sufficiently dilated, and send data and/or results back to aportion of the fluid delivery system 10, for example, the electronicinterface 40.

In alternative embodiments, the external interface 101 may be located onanother portion of housing 20. In addition, the external interface 101may connect or be configured to connect, for example, to other medicalor non-medical devices or nothing at all, to emit a discharge of fluidfrom the fluid delivery system 10 for a variety of uses. The fluiddelivery system 10 may include a universal connector to any one of avariety of distal devices for such uses. Examples of devices and uses inmedical and non-medical applications include:

-   -   a device to perform stone lithotripsy, where the fluid delivery        system may drive a hammer to crush stones that may be, for        example, in the urinary tract;    -   a fastener/staple driver for driving fasteners/staples into        tissue through the use of fluid pressure from the fluid delivery        system, for use in arthroscopy or procedures to treat        gastroesophageal reflux disease (GERD), such as fundoplication        procedures, or full thickness reduction devices;    -   an outgassing packager where compressed gas may drive out        sterilization gas present in a given packaging;    -   a drug injector either configured as an injection system driven        by fluid pressure from the fluid delivery system, or configured        to directly inject fluid containing the drugs from the fluid        delivery system;    -   a device to perform power wash irrigation, for example, for        washing out orifices, hemostatis (stopping bleeding), flushing        out endoscopes, or non-medical applications;    -   a cutting nozzle that is configured to cut tissue or any other        medical or non-medical substance, using the pressurized fluid        from the fluid delivery system;    -   drills, brushes, scrapers, or other like devices for, for        example, dental applications, or other non-medical applications;    -   a cast immobilizer configured to be inflated by the fluid from        the fluid delivery system, for example, to treat broken bones,        fractured bones, and muscle tears, or other non-medical        applications;    -   an organ distender, for example, to test tissue strength.    -   a suction device configured to operate, for example, by        connecting the external interface to the suction device to        create suction, or by preinflating the system and then deflating        the system while it is deployed at the desired location;    -   a biopsy device, for example, a clamping jaw, where the fluid        delivery system may be used to actuate the jaw so as to remove a        small sample of tissue for examination.    -   aspirators, for example, a transbronchial needle aspirator;    -   clamps, where the fluid pressure from the fluid delivery system        may be used to close and/or advance the clamps, for example, in        a biopsy procedure, or other non-medical applications;    -   a viscous material deliverer, which may just be a tube, where        the fluid itself may actually constitute a contrast, such as        renografin, or fillers, for example, for arthroscopy or to fill        abdominal or cranial aneurysms, or other non-medical        applications;    -   a power mixer to mix viscous agents such as fibrin glues,        enteryz, adhesives, epoxies, or other items that may be used for        occlusions, fractures, or as a sealant, or other non-medical        applications;    -   a steerable catheter tip that responds to changes in fluid        pressure;    -   a catheter tube that when fluid is applied to it may stiffen,        for example, during the therapy portion of a biopsy procedure,        or other non-medical applications;    -   a device that heats and/or cools the fluid, so as to deliver        heated and/or cooled fluid to tissue, for example, to treat        ablations, polyps, or warts, or other non-medical applications;    -   a harmonic scalpel or other device where, for example, the        change in fluid pressure causes the scalpel to vibrate;    -   a device that causes a water surge, for example, to move organs        or create downward pressure in the gastrointestinal tract as an        anti-reflux action, or other non-medical applications;    -   a general actuator that actuates, for example, surgical        instruments, or other non-medical applications;    -   a catheter that, based on the fluid pressure, creates vibrations        at ultrasonic frequencies, for example, for diagnostics,        therapeutics, ablations, and cutting, or other non-medical        applications;    -   an expandable brace that may be inflated, for example, to        promote bone growth, or other non-medical applications;    -   a catheter that may bend based on changes in fluid pressure;    -   a pressure cuff that may be inflated and deflated around parts        of the body, for example, to measure blood pressure or stimulate        blood flow, or other non-medical applications;    -   a stent deployer where the control of the fluid pressure may        allow the controlled deployment of the stent in the desired        bodily location, or other non-medical applications;    -   a tissue insufflator that may deploy gas or powder into a body        cavity, for example, during laparoscopic surgery;    -   a trocar that may draw off fluids from a body cavity;    -   a rotational snare that uses fluid pressure to drive and/or spin        the snare;    -   a telescoping guidewire that may use fluid pressure to advance        movement of the distal end of the guidewires, for example,        through difficult lesions, or other non-medical applications;    -   a drug pack, where the drug packs is loaded into a housing and        then may be compressed by the fluid when delivery is desired, or        other non-medical applications;    -   a drug pump, where the fluid pressure may drive a temporary or        permanent drug pump to infuse drugs into the body, or other        non-medical applications;    -   a needle driver which may assist in pushing needles into, for        example, hard lesion or bones, or other non-medical        applications;    -   a device that may control the delivery of ligation bands, for        example, around a blood vessel to stop it from bleeding or        another structure to constrict it;    -   inflatable bolsters on PEG tubes;    -   inflatable anchors on various catheters;    -   a bougie used to enlarge strictures and powered by the fluid        pressure to inflate and/or deflate to multiple sizes;    -   a cystic fibrosis impactor powered by compressed fluid that may        be used to provide force to the lungs;    -   an inflatable stent that could have a low profile delivery but        able to be rigidly deployed;    -   a power mechanical dilator for extending, for example, a mesh or        a linkage within the body, or other non-medical applications;    -   a device for delivering bulking agents such as enteryx for GERD        treatment and collagens;    -   an intra-aortic balloon pump that may be relatively small        because a compressor may no longer be necessary;    -   an intravenous bag so as to replace and/or improve on the        gravity driven intravenous bag by controlling fluid output;    -   a catheter to serve as a portable catheter leak test;    -   a device which may use compressed gas to drive undesired gas out        of a given environment;    -   an injector to control the injection of a substance into a        desired location;    -   a power wash irrigator to washout a desired device or location;    -   a balloon inflation device;    -   a toy projectile so as to use the fluid pressure to propel the        toy projectile, such as a nerf ball, other toy balls, or toy        discs;    -   a water gun;    -   a tattoo needle where the fluid pressure drives the needle and        the colors may be selected from a color wheel;    -   a rotator where the fluid pressure drives the rotation of the        rotator;    -   a power mechanical dilator for extending, for example, a mesh or        a linkage;    -   an inflator to inflate toys.    -   construction applications requiting a high pressure fluid jet        (i.e. cutters); or    -   toys such as water guns;

In adapting the fluid delivery system 10 for use with systems in, forexample, the medical and non-medical applications described above,portions of the fluid delivery system 10 may need to be reconfigured oradapted in order to meet the requirements of the medical and/ornon-medical applications and/or uses.

In an exemplary embodiment, the hydraulic assembly 100 and/or pneumaticassembly 60 may be configured to have an exterior double seal systemaround the hydraulic assembly 100 and/or pneumatic assembly 60 so as toprovide a backup system for preventing leakage from either assembly. Theentire fluid delivery system 10, or at least its sensitive portions, arepreferably hermetically sealed so as to avoid mold, bacteria, and dirt.

In an embodiment, the fluid delivery system 10 may be a single usesystem that may be disposed of after a single use. In anotherembodiment, the fluid delivery system 10 may be a portable home kit thatis configured to allow self-dilatation. In yet another exemplaryembodiment, the fluid delivery system 10 may be reusable. According tothat embodiment, at least components or portions of the fluid deliverysystem 10 may be disposable and/or replaceable, for example, as the lifeof the component runs out or to maintain sterility in the case ofcomponents that contact a patient. For example, the hydraulic assembly100, or at least its fluid containing portion, may be configured to beremoved from within the housing 20 of the fluid delivery system 10 andreplaced. In another example, the gas cartridge 63 may be configured tobe removed and replaced. In yet another example, the battery from theelectronic interface 40 may be configured to be removed and replaced.The electronic interface and circuitry may be configured to indicate toa user that a component may be in need of replacement.

As a further example, the external interface 101 may be configured toselectively attach to any number of distal components through anysuitable attachment mechanism known in the art. Such distal components,such as balloon dilator 200 or any other medical or non-medical device,may be sold separately and have universal, standard attachment means atits proximal end to attach to the external interface 101 of the fluiddelivery system 10 prior to use. After use, the distal component may bereplaced/disposed, with the fluid delivery system 10 being reusable.

In various embodiments, many of the parts in the fluid delivery system10 may be injection molded, for example, with plastic or other suitablematerial. The components, however, may be made of other materials usinga variety of other methods, for example, machining or casting metal. Inaddition, certain parts are preferably made of biocompatible materials,including those parts in contact with a patient. In another example, thematerials of the fluid delivery system 10 and/or the packaging used toship the fluid delivery system 10 may be made of environmentallyfriendly materials. The system 10 is preferably made out of materialthat do not corrode or deteriorate during shelf life, preferably do notleak fluids during shelf life, preferably is made out of materials thatcan perform after shelf life, and preferably withstand sterilityconcerns.

In yet another embodiment, the fluid delivery system 10 may beconfigured as a dual action system. For example, the fluid deliverysystem 10 may be configured to have two external interfaces 101configured to connect to two different external devices, for example,two different balloon catheters or two balloons of the same catheterwith each balloon having a separate inflation lumen. These externalinterfaces may be separately controlled by separate elements on thefluid delivery system 10, for example, separate triggers actuatingseparate pneumatic assemblies 60 and/or hydraulic assemblies 100connected to separate external interfaces. However, the externalinterfaces may also be controlled by the same elements on the fluiddelivery system 10, for example, the same trigger actuating the samepneumatic assembly 60 and/or hydraulic assembly 100 connected to theseparate external interfaces. In such a fluid delivery system 10, theexternal interfaces may work in conjunction, meaning that both externalinterfaces may dispense fluid simultaneously in the same amount.However, in another example, the fluid delivery system 10 may beconfigured so that even though the external interfaces are controlled bythe same components, the user has the option of dispensing fluid fromonly one of the external interfaces and not the other.

In still another embodiment, the fluid delivery system 10 may beconfigured as multiple function system. For example, the fluid deliverysystem 10 may have multiple valves, multiple ports, and multipleactuators to perform multiple functions. In an example of such a device,a user may actuate a button to fill a balloon catheter attached to anexternal interface of the fluid delivery system 10, but then may actuateanother trigger to actuate some other medical function, for example, adrill. In this way, the dispensation of fluid may be just one of manyfunctions of the fluid delivery system 10.

In another exemplary embodiment, the gas cartridge 63 may actually be agas system that can provide gas pressure to the pneumatic assemblywithout necessarily requiring an internal gas cartridge 63. For example,the gas system may be a compressed gas reservoir located in a hospital,a small onboard compressor, a gas cartridge loaded on a separate device,or a hand pump.

In another exemplary embodiment, the fluid delivery system 10 may glowin the dark or may have appropriate buttons and lights for enabling thedevice to light up. This may be desirable as many laboratories are oftenkept in dark conditions.

In an exemplary embodiment, the entire fluid delivery system 10, or justportions of the fluid delivery system 10, may be automated andcontrolled with various feedback loops and/or software.

In a further embodiment, the fluid delivery system 10 may use othersources of power, for example, power sources already present in thesetting that the devices is used, for example, a hospital. In such acase, the device may include suitable power source connectors forconnection to the power source.

The fluid delivery system 10 described and depicted in connection withFIGS. 1-6 d is an exemplary embodiment. Other combinations of parts andcomponents are contemplated, such as those depicted in FIGS. 7 a-7 f.

For example, the fluid delivery system 10 may be in the shape of asword-like handle, as depicted in FIG. 7 a, where a handle grip portion210 contains both the pneumatic assembly and the hydraulic assembly, andthe electronic interface portions, for instance the indicators 211 andbuttons 212 that function similar to their counterparts depicted inFIGS. 6 a-6 d, may be disposed on various parts of the handle gripportion 210. It is also contemplated, however that the buttons 212 mayfunction as deflation buttons which may, when depressed, automaticallydecrease the pressure in the hydraulic assembly to one or morepredetermined amounts. In this exemplary embodiment, the externalinterface 214 may be located where the shaft of the sword would leavethe handle portion 210, the inflation trigger 213 may be located on thetop of the handle portion 210, and the gas cartridge 215 may be locatedon the back of the handle portion 210.

In another exemplary embodiment, the fluid delivery system 10 may beconfigured in a joystick-like shape, similar to a video game joystick,as depicted in FIG. 7 b. In this embodiment, movement of the joystick220 would act to increase and/or decrease the pressure in the fluiddelivery system. The indicators 221 and button 224, which functionsimilar to their counterparts depicted in FIGS. 6 a-6 d, may be on topof the device next to the joystick 220, the rapid deflation button 222may be on the front of the device, and the entire device may be poweredon by twisting an auxiliary portion 223 of the device or flipping aswitch on auxiliary portion 223.

In yet another exemplary embodiment, the fluid delivery system 10 mayhave a gun-style shape as depicted in FIG. 7 c. This embodiment issimilar to the exemplary embodiment depicted in FIGS. 1-6 e, as it mayhave a handle portion 243 with a trigger 244 located forward of thehandle portion 243. However, the indicators 240, which function similarto their counterparts depicted in FIGS. 6 a-6 d, may be on the side ofthe device, the deflation button 245 may be on the handle portion 243,and the gas cartridge 241 may protrude out of the proximal end 242 ofthe device.

In still another exemplary embodiment, the fluid delivery system 10 maybe configured in a joystick-like shape, similar to that used for controlof an airplane, as depicted in FIG. 7 d. Some features of thisembodiment may include a joystick 232 which may control the increaseand/or decrease of pressure in the device, rapid deflation button 230 ona finger accommodating portion 237 of the joystick handle 235, actuationby twisting a bottom portion 236 of the device around its central axis,a replaceable hydraulic assembly through a top cartridge 234 of thedevice, and indicators 231 and an electronic interface button 233, whichfunction similar to their counterparts depicted in FIGS. 6 a-6 d, alsolocated on the top of the device.

In other exemplary embodiments, FIGS. 7 e-7 f depict aestheticallydifferent exemplary embodiments of the fluid delivery system. Theexemplary embodiments may include handle portions 250, 260 withinflation triggers 251, 261 on one side and deflation buttons 252, 262on the other. The exemplary embodiments may also have indicators 253,263 located on top of the handle portions 250, 260. In addition, one ofthe exemplary embodiments may be powered on by twisting a bottom portion264 about its central axis.

An exemplary method of using the embodiment of the fluid delivery systemdepicted in FIGS. 1-6 d will now be described. As an initial step, theuser must access the treatment site in a patient through any suitablemethod known in the art. For example, the embodiment shown in theseFigures may be used in an endoscopic procedure that uses an endoscope togain access to a treatment site, such as a stricture within anesophagus. According to that method, the user may use any suitableendoscope having a lumen that may accommodate the balloon dilator 200when balloon 202 is in an uninflated state. Once the user accesses thetreatment site with the endoscope through a conventional method, theuser may advance balloon dilator 200 through the lumen until it exitsthe distal end of the endoscope lumen at the treatment site. Anysuitable, known methods of visualizing the site during the procedure anybe used, including imaging techniques.

Once balloon 202 is properly positioned at the treatment site, the usermay depress the trigger interface 83 of the inflation trigger 61 toinitiate inflation of balloon 202. To continue inflation of the balloon202, the user may thereafter release the trigger interface 83 of thetrigger and allow the fluid delivery system to automatically inflate theballoon 202, or the user may continue to hold down the trigger interface83 of the inflation trigger 61 to continue inflation of the balloon 202.

Depressing the inflation trigger 61 may cause the trigger interface 80to move toward the trigger controlled passage 85 and the gas cartridgeinterface 66, and in particular may cause the trigger interface shaft175 to move deeper into the insertion portion 198 of the gas triggerinterface 66 through the insertion opening 260. This movement of thetrigger interface shaft 175 may move gas cartridge interface ball 177away from the insertion opening 260 of the insertion portion 198, andmay unseal the insertion opening 260 to allow fluid communication fromthe chamber portion 199 of the insertion portion 198, through theinsertion opening 260, through the trigger controlled passage 85 andinto the trigger interface chamber 75. Some fluid may try to flow intothe hollow portion of the trigger interface shaft 175, but it may beblocked, for example, by the trigger plug shaft 174 of the triggerinterface plug 172.

The movement of the gas cartridge interface ball 177 away from theinsertion opening 260 on the gas cartridge interface 66 may in turncause the gas cartridge interface spring 179 to compress. Thecompression of the gas cartridge interface spring 179 may in turn causethe movement of the gas cartridge interface plug 180 away from insertionportion 198 of the gas cartridge interface 66 and cause some compressionof the gas cartridge stopper O-ring 185 either between the gas cartridgeinterface plug 180 and the gas cartridge 63, or between the gascartridge interface plug 180 and the wall of the interface portion 261of the gas cartridge interface 66. The movement of the gas cartridgeinterface plug 180 away from insertion portion 198 of the gas cartridgeinterface 66 may also cause the cartridge interface end 264 to move awayfrom the interior opening 262 and come into contact with a portion ofthe gas cartridge 63. The contact may cause fluid to flow, for example,from the gas cartridge 63, through at least a portion of the gascartridge receiver 182 on the interface portion 261 of the gas cartridgeinterface 66, into the gas cartridge interface plug passage 181 disposedin the gas cartridge interface plug 180 and into the chamber portion 199of the insertion portion 198 of the gas interface cartridge 66. The gascartridge receiver O-ring 184 and the gas cartridge stopper O-ring 185may be configured to prevent fluid from flowing out of the interfaceportion 261 and into the external environment.

Once the fluid flows from the gas cartridge 63, through the interfaceportion 261 and insertion portion 198 of the gas cartridge interface 66,through the insertion opening 260, the fluid intake chamber 74, and thetrigger controlled passage 85 into the trigger interface chamber 75, thefluid may flow through the interchamber passage 81 and into at least aportion of the fluid transfer chamber 73. Initially, the fluid may notflow well through the interchamber passage 81 because the fluid transferball 169 is lodged and covering the opening of the interchamber passage81 in the fluid transfer chamber 73. However, enough fluid pressure maybuild up in, for example, the trigger interface chamber 75 that thefluid transfer ball 169 may be forced by the buildup in pressure in thetrigger interface chamber 75 to move away from the interchamber passage81 and allow fluid flow into the fluid transfer chamber 73. From thefluid transfer chamber 73, the gas may flow through the fluid connector67 into a portion of the hydraulic assembly 100. In an exemplaryembodiment, although some fluid may flow into the deflation valvepassage 167 and attempt to flow into the relief cap interface chamber76, it may be blocked by the deflation ball 166 lodged in the opening ofthe deflation valve passage 167.

The gas may flow from the fluid connector 67 into the hydraulic stem 110of the hydraulic assembly 100. The gas then flows in the hydraulic stem110 from the pneumatic interface 119, through the shaft 118, and out thehydraulic cylinder interface 120 into the hydraulic cylinder 102. Moreparticularly, the gas flows from the hydraulic cylinder interface 120 ofthe hydraulic stem 110 into the hydraulic stem interface 121 of thehydraulic cylinder 102, and into at least a portion of the fluid chamber127 of the hydraulic cylinder 102. Once inside the fluid chamber 127,the gas contacts at least a portion of the proximal wall 134 of theprimary piston 105, which initially may be in contact with or at leastadjacent to the proximal wall 122 of the hydraulic cylinder 102. As thesidewall 133 of the primary piston 105 and the inner surface 125 of thesidewall 124 of the hydraulic cylinder 102 may form, with or without theassistance of a primary piston O-ring 112, a fluid tight and/orhermetical seal, the introduction and/or accumulation of gas into thefluid chamber 127 places pressure on several walls and, in particular,the proximal wall 134 of the primary piston 105.

As this pressure builds on the proximal wall 134 of the primary piston105, in this exemplary embodiment, the primary piston 105 may begin tomove away from the proximal wall 122 of the hydraulic cylinder 102. Asthe primary piston 105 moves, it may compress primary piston spring 113.As described above, the primary piston spring 113 contacts on one end aspring receiver 130 on the primary piston 105, and on the other end theproximal wall 156 of the central portion 154 of the hydraulic cap 104.As the primary piston 105 moves away from the proximal wall 122 of thehydraulic cylinder, the hydraulic cap 104 may remain stationary, forexample, because it is locked relative to the hydraulic cylinder 102.Thus, the primary piston spring 113 compresses between the primarypiston 105 and the hydraulic cap 104.

The movement of the primary piston 105 may also cause the flow of fluidwhich may be present in the portion of the fluid chamber 127 bounded bythe primary piston 105, sidewall 124 of the hydraulic cylinder 102, andthe proximal portions (proximal end 140, proximal sidewall 142, proximalwall 148) of the hydraulic cap 104. The fluid may comprise any liquid orother material capable of filling a balloon dilator 200, for example,water, saline, propylene glycol, or mineral oil. In various embodiments,the fluid may flow in a plurality of ways and/or to a plurality ofplaces, for example, out of the fluid chamber 127. However, anyconfiguration that, due to the increases in gas pressure, increases thevolume of the fluid chamber 127 bounded by the primary piston 105,sidewall 124 of the hydraulic cylinder 102, and the proximal portions(proximal end 140, proximal sidewall 142, proximal wall 148) of thehydraulic cap 104 is acceptable.

In this exemplary embodiment, one place the fluid may flow is throughthe proximal opening 148 of the external interface connector 147,through the external interface connector 147, and out the distal opening149 of the external interface connector 147. From there, the fluid mayflow directly into external interface 101 or through at least one luerhub 108 into external interface 101. Alternatively, the externalinterface connector 147 may be the external interface 101. The fluidthen flows out of the fluid delivery system 10 and into, for example,catheter 201 of balloon dilator 200 to inflate balloon 202.

Another place the fluid may flow is through the proximal opening 141 ofthe proximal end 140 of the hydraulic cap 104 into the inner chamber 153of the hydraulic cap 104. There, the fluid may come into contact with atleast a portion of the proximal wall 161 of the expansion piston 106.Accordingly, as the sidewall 162 of the expansion piston 106 and theinner surface 150 of proximal sidewall 142 of the hydraulic cap 104 mayform a fluid tight and/or hermetical seal, with or without theassistance of an expansion piston O-ring disposed between the sidewalls142, 162, fluid pressure may build against the proximal wall 161 of theexpansion piston 106. As this pressure builds, the expansion piston 106may move away from the proximal end 140 of the hydraulic cap 104 andtoward the distal protrusions 143 of the hydraulic cap 104. In doing so,the expansion piston 106, which may be connected to or at least be incontact with an expansion spring 114, may cause the expansion spring 114to compress between, for example, the spring receiver 165 of theexpansion piston 116 and the spring retainer 107. The spring retainer107 may be connected to a portion of the housing 20, for example,beneath the external surface notch 23, and between the structuralsupport 33 and connector 27 a in the distal portion of the housing 20,and may not move relative to the housing 20.

In an exemplary embodiment, it is contemplated that the expansion piston106, expansion spring 114, and hydraulic cap 104 assembly may beconfigured so that the expansion piston does not move completely pastthe central portion 154 of the hydraulic cap 104 and into the portion ofthe inner chamber 153 between the distal protrusions. This may be toprevent a fluid seal from being broken in the hydraulic assembly 100.For example, the assembly could be designed such that the maximumcompression of the expansion spring 114 does not allow the expansionpiston 106 to move past a certain point distally, or that the expansionpiston 106 may have a distal opening 167 leading to an inner chamber 163with a chamfered proximal end 166 in the proximal wall 161 configured toreceive the proximal end of the spring retainer 107, and thus limit thedistal movement of the expansion piston 106. However, any energy storagesystem that stores energy due to changes in fluid pressure, for example,in the hydraulic assembly is acceptable.

Fluid also may flow into the proximal opening 145 of the check valveconnector 144, through the check valve connector 144, through the distalopening 146 of the check valve connector 144, and into at least aportion of the check valve 115 through, for example, the hydraulic capinterface 175. In another exemplary embodiment, the fluid may already bepresent in at least a portion of the check valve 115. Initially, thecheck valve 115 may be configured to prevent fluid flow out of the checkvalve 115, despite building fluid pressure due to the fluid flow inother parts of the hydraulic assembly 100. For example, the interior ofthe check valve 115 may be configured to prevent fluid flow, or thevalve cap 180 may be configured to prevent fluid flow.

Fluid also may flow through the pressure sensor port 152 of thehydraulic cap 104 and into a portion of the pressure sensor subassembly116, for example, the fluid intake opening 187 of the hydraulic capinterface 185. However, the pressure sensor subassembly may not have afluid intake opening 187, and instead may take pressure or othermeasurements on an exterior surface. In another exemplary embodiment,the fluid may already be present in at least a portion of the pressuresensor subassembly 116. The electronic housing 186 of the pressuresensor subassembly 116 may have electronics, circuits, or other meansconfigured to measure pressure, or take other readings, from the fluid.The pressure sensor subassembly 116 may continuously take such fluidreadings, or periodically take them.

In an exemplary embodiment, the electronic housing 186 of the pressuresensor subassembly 116 may transmit a signal, for example, the pressurereadings, from the pressure sensor subassembly 116 to the electronicinterface 40. These signals may be transmitted by wire, radio waves, orany other suitable methods. The signals may be received in theelectronic interface 40 by the pressure sensor header connector 44,which may be disposed on the electronic interface board 54. From there,the electronic interface 40 may house electronic components within theelectronic interface housing 53 to convert the signals and display themon the display 41. For example, the display 41 may show a timer,pressure readings, size readings (for example, for a balloon dilator),or any other type of relevant information, including having indicatorsthat show the same reading as the other indicators 49, 50.

The electronic interlace 40 may also have indicators 49, 50 whichindicate, for example, when the pressure readings from the pressuresensor subassembly 116 reach certain thresholds (for example, indicators49 a), or indicate whether the pressure in the hydraulic assembly 100 isincreasing or decreasing (for example, indicators 49 b). For example, inthe case of balloon dilators, specific pressure measurements mayindicate specific desired balloon sizes. Using this information, a usermay, for example, release the inflation trigger 61 and prevent furtherfluid flow in the hydraulic assembly 100 when the electronic interface40 indicates that the balloon has reached a certain size, or theelectronic interface 40, without the input of the user, mayautomatically send a signal to either the hydraulic assembly 100 or thepneumatic assembly 60 to automatically stop the fluid flow when itreceives measurements that indicate the balloon has reached a certainsize. Once again, the use of balloon sizes in conjunction withindicators is exemplary, and any similar measurements that require suchindications is also contemplated.

The electronic interface 40 may, when certain readings are received fromthe pressure sensor subassembly 116 and/or processed, emit a sound, forexample, from the audio beeper 48. In one exemplary embodiment, thesound from the audio beeper 48 could coincide with the indication fromthe indicator 49, 50. The user may heed these indications and, forexample, release the inflation trigger 61 to halt the increase of gaspressure within the pneumatic assembly 60. The electronic interface mayalso have a mute button to allow the user to silence the audio beeper48.

The electronic interface 40 may also have an indicator that indicatesthere is an error in the system, for example, indicator 49 c. Someerrors may be, for example, the system is overloading, there is nopower, or the electronic interface 40 is not receiving any signals. Ifthe user sees this error indicator 49 c or other indicators 49, 50, theuser may, for example, press the deflation button 62 and cause thedepressurization of the pneumatic assembly 60, or initiate the rapiddepressurization valve and cause the rapid equalization of gas pressurebetween the gas chamber portions of the pneumatic assembly 60 and theoutside environment. In another embodiment, the depressurization of thepneumatic assembly 60 may be automatic, and not require any input fromthe user.

Once the fluid delivery system 10 is given an indication that fluid flowis to cease, the following may occur. The indication may be a manualindication done by the user, for example, by releasing the triggerinterface 83 of the inflation trigger 61, or an automatic indicationdone by the electronic interface 40, for example, when the pressureand/or size measurements reach a predetermined level. In an exemplaryembodiment, once the fluid delivery system 10 receives the indication tocease gas flow, the pneumatic valve may be configured to stop gas flowwithin, for example, 500 ms. In another example, the indication to ceasegas flow may be that the gas pressure in the pneumatic valve 70 reachesa predetermined maximum value, in which case the high pressure valves 91on the relief cap 90 may be configured to automatically release gas outof the chambers in the pneumatic valve 70. This may be done whether ornot the user has given the manual indication to stop, for example, byreleasing the inflation trigger 61.

In one exemplary embodiment, a valve spring may be located in thetrigger interface chamber 75, and be connected to, or at least incontact with, on one side by a portion of the inflation trigger 61, andon the other side by a portion of the valve body 84 of the pneumaticvalve 70. Accordingly, when the user releases the trigger interface 83of the inflation trigger 61, the valve spring may cause the inflationtrigger 61 to pivot away from the pneumatic valve 70, the hinge 68possibly being the rotational axis of the inflation trigger 61. Whenthis occurs, the inflation trigger 61 may at least partially cause thetrigger interface 80 to move away from the gas cartridge interface 66and the trigger controlled passage 85, and toward and/or further throughthe trigger opening 87. The movement of the trigger interface 80 mayalso be assisted by the expansion of the gas cartridge interface spring179, as the expansion of the gas cartridge interface spring 179 maycause the gas cartridge interface ball 177 to move toward the insertionopening 260 of the insertion portion 198 and become lodged in theinsertion opening 260 and against the gas cartridge interface ballO-ring 178. The movement and lodging of the gas cartridge interface ball177 may cause the trigger interface shaft 175 to move away from theinsertion portion 198 of the gas cartridge interface 66, thus furtherfacilitating movement of the trigger interface 80. Accordingly, the gascartridge interface plug 180, due to the fact that it now has lesspressure on it, for example, from the gas cartridge interface spring179, may again become completely lodged in the interior opening 262 ofthe gas cartridge interface 66.

The movement of the aforementioned elements may cause fluidcommunication to be cut off in several ways. For example, fluidcommunication between the gas cartridge 63 and the gas cartridgereceiver 182 on the interface portion 261 may be cut off due to thecartridge interface end 264 no longer causing fluid to flow from the gascartridge 63. In another example, fluid communication between thechamber portion 199 of the insertion portion 198 of the gas cartridgeinterface 66 and the trigger interface chamber 75 through the triggercontrolled passage 85 and insertion opening 260 may be cut off due tothe gas cartridge interface ball 177 being lodged in the insertionopening 260. In yet another example, fluid communication between thetrigger interface chamber 75 and the fluid transfer chamber 73 throughthe interchamber passage 81 may be cut off due to the fluid transferball 169 being lodged in the portion of the fluid transfer chamber 73abutting the interchamber passage 81. The lodging of the fluid transferball 169 may occur because the fluid pressure from the trigger interfacechamber 75 may no longer be as great as the expansion pressure from thefluid transfer spring 170.

Thus, because at least of the above elements may prevent further fluidflow through the pneumatic valve 70, the fluid may stop flowing from thefluid transfer chamber 73, through the fluid connector 67 and hydraulicstem 103 into the hydraulic cylinder 102. This stop in gas flow may stopthe movement of the primary piston 105 away from the proximal wall 122of the hydraulic cylinder 102, and thus may stop the fluid flow from thehydraulic cylinder 102 into various portions of the hydraulic cap 104,for example, the inner chamber 153 of the hydraulic cap 104, the checkvalve connector 144, the pressure sensor port 152, and the externalinterface connector 147.

In various embodiments, the user, once the gas flow to the pneumaticassembly 60 and/or fluid pressure buildup in the hydraulic assembly 100has stopped, may reinitiate the process of increasing the gas pressureand/or fluid pressure in the pneumatic assembly 60 and/or hydraulicassembly 100 by, for example, again depressing the inflation trigger 61.This may be desirable, for example, to increase the size of the balloondilator 200 to the next desired size. Accordingly, the entire abovedescribed fluid flow method may be repeated.

In an exemplary embodiment, the user may deflate the fluid deliverysystem 10. In an exemplary embodiment, once the deflation signal isgiven, the fluid delivery system 10 may be configured to deflate aballoon dilator 200 and/or take in fluids from the external interface101 for an amount of time, for example, about 20-30 seconds. Forexample, the user may trigger the deflation button 62, which may causethe deflation interface 65 on the relief cap 90 to move the deflationshaft 160 and the deflation ball interface 163 toward the proximal end190 of the relief cap 90. The movement of the deflation shaft 161 maycause the deflation spring 161 to compress between the deflation springreceiver 189 and the portion of the relief cap 90 surrounding theproximal end 190. The movement of the deflation ball interface 163 maycause the deflation ball 164, previously lodged in and preventing fluidcommunication through the deflation valve passage 167, to becomeunsealed and allow fluid communication between the fluid transferchamber 73 and the portion of the relief cap interface chamber 76between the deflation valve legs 188. The deflation valve shaftreceivers 193 on the deflation valve legs 188 may prevent movement ofthe deflation shaft and 160 and deflation ball interface 163 too fartowards the proximal end 190 of the relief cap 90 by virtue of thembutting up against the deflation leg receivers 194 on the deflationshaft positioners 162.

Due to the movement of the deflation ball interface 163, andconsequently the deflation ball 166 away from the deflation valvepassage 167, fluid may flow from the fluid transfer chamber 73, throughthe deflation valve passage 167, through the gap between the deflationvalve 166 and the deflation ball interface 163, into the relief capinterface chamber 76, and then out into the external environment. Theflow of fluid out into the external environment may be, for example,through the opening in the proximal end 190 of the relief cap 90 wherethe deflation interface 65 is located, or through the gap between thegrooved portion 72 on the valve body 84 and the grooved portion 186 onthe relief cap 90. Accordingly, at least some the pressurized gas mayflow and/or escape from the pressurized gas system, the pressurized gassystem possibly comprising the relief cap interface chamber 76, thefluid transfer chamber 73, the trigger interface chamber 75, and atleast a portion of the fluid chamber 127 of the hydraulic cylinder 102.

In another exemplary embodiment, if the user wanted to cease deflatingthe balloon dilator 202, the user may release the deflation button 62,which may cause the deflation interface 65 to cause the deflation shaft162 and deflation ball interface 163 to move toward the deflation valve166. This may be due at least partially to the expansion of thedeflation spring 161 against the portion of the relief cap 90surrounding the opening in the proximal end 190 and the deflation springreceiver 189. The movement of the deflation shaft 162 and the deflationball interface 163 may also be at least partially due to the realignmentof the spring-like deflation shaft positioners 162 as they act against,for example, the deflation valve legs 188. The movement of the deflationball interface 163 away from the proximal end 190 of the relief cap 90may cause the deflation ball 164 to become lodged against the deflationvalve 166 and cover the deflation valve passage 167 so as to preventfurther fluid communication through the deflation valve passage 167.

In another embodiment, there may also be a rapid depressurization valve,either on the relief cap 90, the pneumatic assembly 60, or the hydraulicassembly 100, which when triggered opens a direct and continuous flowcommunication channel from the pressurized gas system to the externalenvironment.

In another embodiment, there may also be a high pressuredepressurization valve 91, either on the relief cap 90, the pneumaticassembly 60, or the hydraulic assembly 100, which when triggered opens adirect and continuous flow communication channel from the pressurizedgas system to the external environment. Unlike the other deflation ordepressurization systems, however, the high pressure depressurization isautomatic in that when the pressure in the aforementioned pressurizedgas system gets to what has been predetermined as being an excessivelevel, the high pressure depressurization valve 91 automatically opens adirect and continuous flow communication channel from the pressurizedgas system to the external environment. Once the pressure in theaforementioned pressurized gas system, however, ceases to be at theexcessive level, the high pressure depressurization valve 91 may ceaseor close the direct flow communication from the pressurized gas systemto the external environment.

For example, when the pressure in the relief cap interface chamber 76reaches a predetermined maximum level, the fluid pressure on the poppetball may move the poppet ball away from the interface portion. Themovement of the poppet ball may compress the poppet spring, and thus therelief cap interface chamber 76 be in fluid communication with theexternal environment via the poppet valve 91. Once enough fluid has leftthe relief cap interface chamber 76 such that the pressure in the reliefcap interface chamber 76 falls below, for example, the predeterminedmaximum level, the poppet spring may expand and relodge the poppet ballin the poppet valve 91, thus ceasing the fluid communication between therelief cap interface chamber 76 and the external environment.

This flow and/or escape of gas from the pressurized gas system, eitherthrough user initiated regular deflation or rapid depressurization, orautomatic depressurization through high pressure depressurizationvalves, may cause the gas pressure in, for example, the aforementionedpressurized gas system to fall. This reduction in gas pressure may causethe primary piston 105 to move toward the proximal wall 122 of thehydraulic cylinder 102 in a variety of ways. For example, the reductionof gas pressure at least in the portion of the hydraulic cylinder 102between the proximal wall 122 and proximal wall 134 of the primarypiston 105 may create a vacuum, causing this vacuum to “tug” on theproximal wall 134 of the primary piston 104 and reduce the volume of thepressurized gas system. However, other forces may also be at work toreduce the pressure and/or volume of the pressurized gas system.

In another embodiment, the reduction in gas pressure in the pressurizedgas system may cause the expansion piston spring 114, which is currentlycompressed, to expand and push the expansion piston 106 toward theproximal opening 141 in the proximal end of the hydraulic cap 104. Inanother embodiment, the primary piston spring 113, which is currentlycompressed, may expand and push the primary piston 105 toward theproximal wall 122 of the hydraulic cylinder 102. In another embodiment,this movement of the primary piston 105 toward the proximal wall 122 ofthe hydraulic cylinder 102 and away from the proximal end 140 of thehydraulic cap 102 may create a negative fluid pressure in the fluidsystem, which may comprise at least a portion of the fluid chamber 127of the hydraulic cylinder 102, the fluid chamber 136 of the primarypiston 105, at least a portion of the inner chamber 153 of the hydrauliccap 104, portions of the central portion 154 of the hydraulic cap 104,and external device to which the external device interface 101 may beconnected. Accordingly, this negative fluid pressure may cause some ofthe fluid that had previously been ejected from the fluid deliverysystem 10 to reenter the device through the external device interface101.

In an exemplary embodiment, this negative fluid pressure and/or flow offluid back into the fluid delivery system 10 may cause the pressuresensor subassembly 116, which may be lodged in the pressure sensor port152 of the hydraulic cap 104, to send readings to the electronicinterface 104. The electronic interface 40 may receive the readings, forexample, through the pressure sensor header 44 on the electronicinterface feature board 54. Once receiving the readings, the electronicinterface 40 may process the readings and output variations of thereadings. For example, the electronic interface 40 could display on theelectronic display 41 the current pressure/size readings, and the timethe entire fluid delivery system 10 has been in use or otherwise. Inanother example, the electronic interface 40 may trigger and/orilluminate various indicators 49, 50, for example, the down indicator 49b-1, which may indicate that the pressure in the system is decreasing,and/or the pressure/size indicator lights 49 a, 50, which may indicatewhen, for example, a balloon catheter has deflated down to variouspressures/sizes.

In another exemplary embodiment, the check valve 115 may used as a failsafe component of the fluid delivery system 10. For example, in casethat the pneumatic assembly 60 does not function properly andappropriate gas and/or gas pressure is not delivered to the hydraulicassembly 100, the check valve 115 could be used to introduce fluid intothe hydraulic assembly 100 and facilitate the flow of fluid out of thefluid delivery system 10 via the external interface 101. For example, aneedle or other similar device could be inserted into the externalinterface opening 179 of the valve cap 180. Then fluid could be pumpedfrom the needle or other similar device, into the check valve 115,through the flexible interface extension 176, into the hydraulic capinterface 175, and into the hydraulic cylinder 102 via the centralportion 154 of the hydraulic cap 104. As the primary piston 105 is, inits initial position, substantially flush with the proximal wall 122 ofthe hydraulic cylinder 102, one way the fluid chamber 127 couldcompensate for the fluid being inserted through the check valve 115would be to send fluid out of the external interface 101. Accordingly,the external device, for example, a balloon dilator 200, could be filledthrough the use of the check valve 115.

In another embodiment, should the pneumatic assembly 60 not functionproperly and gas cannot be released from the pneumatic assembly 60 dueto a malfunction in, for example, the relief cap 90, the check valve 115could be used to remove fluid from the hydraulic assembly 100. In oneexemplary embodiment, this could be done by placing a needle or similardevice into the external interface opening 179 of the valve cap 180.Then, by drawing fluid out of the check valve 115 through the needle orother similar device, a negative fluid pressure could be created in thehydraulic assembly 100. While the movement of the primary piston 105toward the hydraulic cap 104 may compensate for at least some of thefluid volume lost through the use of the needle, it may not be able tocompensate for the entire loss, as a combination of the negativepressure that would be created by the gas present in the hydrauliccylinder 102, the resistance to compression of the primary piston spring105, and the primary piston 105 attaining its minimum possible physicalseparation from the hydraulic cap 104 would prevent the movement of theprimary piston 105 for compensating for all of the fluid loss.Accordingly, some of the fluid loss may have to be compensated for bydrawing some fluid back into the hydraulic assembly 100 of the fluiddelivery system 10 through the external interface 101.

In an exemplary embodiment, the fluid delivery system 10 may be used inconjunction with an endoscope and a balloon dilator to treatgastrointestinal strictures, or other internal diseases. The balloondilator, which may be connected to a catheter, could be run down theworking channel of an endoscope that is positioned at the desiredlocation within a patient's gastrointestinal tract or other desiredplace within the patient's body. The balloon dilator may then bedeployed, for example, at a desired stricture's location. The fluiddelivery system 10 could then be used to fill the balloon dilator 200 tothe desired size, for example, by filling the balloon dilator 200through the external interface 101 via a catheter. Then, after holdingthe balloon dilator at the desired size for the desired length of time,the balloon dilator could either be increased in size, or could bedeflated using the fluid delivery system 10. Once the balloon dilatorwas deflated, it could then be removed from the gastrointestinal tract,or other body portion, via the working channel of the endoscope.

In another exemplary embodiment, the balloon dilator may be porous, andthe fluid in the fluid delivery system 10 may be a chemical.Accordingly, introducing the chemical into the porous balloon dilatorcould allow the porous balloon dilator to introduce the chemical at adesired location within the body. In another embodiment, the chemicalmay be introduced into the fluid contained within the fluid deliverysystem 10 through the check valve 115. In yet another embodiment,contrast may be introduced into the fluid contained within the fluiddelivery system 10 through the check valve 115.

In another exemplary embodiment, the fluid delivery system 10 with theballoon dilator 200, when in use with an endoscope, may be attached tothe endoscope, for example, through the use of Velcro-like fasteners orother adhesion devices, or be more permanently attached, so as toincrease control and/or free up hands. Generally, the fluid deliverysystem 10, and any attachments, may be used in conjunction with anendoscope. For example, in a fluid delivery system 10 with the balloondilator 200, the balloon dilator 200 may be fed down the working channelof an endoscope.

In another exemplary embodiment, a chemical may be introduced into thehydraulic assembly 100 through the check valve. 115. For example, acontrast solution, photoluminescent dye, or radioactive trace chemicalscould be introduced into the fluid contained with the hydraulic assembly100 through the check valve 115.

In yet another embodiment, the fluid delivery system 10 may use a closedfeedback loop to control the fluid delivery system 10. For example,fluid delivery system 10 may have portions, for example, capacitors,configured to detect the size of the balloon. Based on that information,portions of the fluid delivery system 10, for example, the electronicinterface, may automatically control balloon inflation and/or deflationrates through electronic manipulation of the hydraulic assembly 100and/or the pneumatic assembly 60 with minimal input from the user.

In another exemplary embodiment, the fluid delivery system 10 may beconfigured with an automatic failsafe system. For example, should aproblem arise in the system (i.e., the balloon breaks or the hydraulicassembly ruptures), the fluid delivery system 10 may be configured todetect such a failure and automatically act. In one example, the fluiddelivery system 10 may shut down all of its components. In anotherexample, the fluid delivery system 10 may be configured to automaticallywithdraw the balloon from its deployed location, for example, throughthe use of an electromechanical pulley or a similar device.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A balloon catheter, comprising: a proximal handleassembly; a catheter attached to the handle assembly and configured toreceive inflation fluid from the handle assembly; and a balloon at thedistal end of the catheter and configured to receive inflation fluidfrom the catheter; wherein the handle assembly comprises: a firstassembly including an actuator connected to a reservoir for releasingpressurized fluid from the reservoir; and a second assembly having aninflation fluid chamber, the second assembly being connected to thefirst assembly to receive pressurized fluid from the first assembly andconnected to the catheter to deliver inflation fluid to the catheter inresponse to receipt of pressurized fluid, wherein the actuator isconfigured to (a) move from a first position to a second positioncausing release of pressurized fluid from the reservoir and (b) movefrom the second position to the first position to stop flow of thepressurized fluid from the reservoir.
 2. The balloon catheter of claim1, wherein the first assembly includes a valve connected between theactuator and the reservoir.
 3. The balloon catheter of claim 2, whereinthe valve includes a fluid intake chamber in fluid communication with atrigger interface chamber via a trigger-controlled passage, a fluidtransfer chamber in fluid communication with the trigger interfacechamber via an interchamber passage, and a relief cap interface chamberin fluid communication with the fluid transfer chamber; wherein thefluid intake chamber is configured to receive an insertion portion of agas cartridge interface, the trigger interface chamber is configured toreceive a trigger interface coupled to the actuator, the fluid transferchamber is configured to receive a ball and spring assembly thatselectively blocks the interchamber passage, the relief cap interfaceportion is configured to receive at least a portion of a deflationvalve, and the fluid transfer chamber is in fluid communication with thesecond assembly via a fluid connector.
 4. The balloon catheter of claim1, wherein the actuator comprises a trigger that is capable uponactuation to automatically release pressurized fluid from the reservoir.5. The balloon catheter of claim 1, further comprising an externalinterface connecting the catheter to the second assembly.
 6. The ballooncatheter of claim 1, wherein the actuator is an electronic switch. 7.The balloon catheter of claim 1, wherein the reservoir is a cartridgecontaining pressurized fluid.
 8. The balloon catheter of claim 1,wherein the first assembly further includes a deflation actuatorconfigured to release pressurized fluid from the first assembly.
 9. Theballoon catheter of claim 1, wherein the second assembly furtherincludes a check valve configured to at least one of inject fluid intothe inflation fluid chamber and remove fluid from the inflation fluidchamber.
 10. A balloon catheter, comprising: a proximal handle assembly;a catheter attached to the handle assembly and configured to receiveinflation fluid from the handle assembly; and a balloon at the distalend of the catheter and configured to receive inflation fluid from thecatheter; wherein the handle assembly comprises: a first assemblyincluding an actuator connected to a reservoir for releasing pressurizedfluid from the reservoir; a second assembly having an inflation fluidchamber, the second assembly being connected to the first assembly toreceive pressurized fluid from the first assembly and connected to thecatheter to deliver inflation fluid to the catheter in response toreceipt of pressurized fluid; a sensor within the handle assembly toobtain a measurement of the fluid in the second assembly; and anelectronic interface to display information relating to the measurement,wherein the actuator is configured to (a) move from a first position toa second position causing release of pressurized fluid from thereservoir and (b) move from the second position to the first position tostop flow of the pressurized fluid from the reservoir.
 11. The ballooncatheter of claim 10, wherein the measurement comprises pressure. 12.The balloon catheter of claim 10, wherein the actuator comprises atrigger that upon actuation automatically causes the sensor to obtainthe measurement of the fluid and the electronic interface to displayinformation relating to the measurement.
 13. The balloon catheter ofclaim 10, wherein the electronic interface includes an indicator forindicating at least one of when the measurement is decreasing and whenthe measurement is increasing.
 14. The balloon catheter of claim 10,wherein the electronic interface includes an indicator for indicatingwhen one or more predetermined measurements are obtained.
 15. Theballoon catheter of claim 10, wherein the electronic interface isoperably connected to the first assembly to shut down fluid flow at oneor more predetermined sizes of the balloon.
 16. The balloon catheter ofclaim 10, wherein the electronic interface is capable of sending asignal to the first assembly to alter fluid flow at one or morepredetermined measurements.
 17. The balloon catheter of claim 10,wherein the electronic interface includes an indicator for emitting asignal in response to one or more states of the balloon catheter. 18.The balloon catheter of claim 10, wherein the electronic interface isconfigured to store data.
 19. The balloon catheter of claim 18, whereindata is stored in an electronic memory.
 20. The balloon catheter ofclaim 18, wherein the stored data includes at least one of one or morepredetermined maximum inflation fluid measurements and one or morepredetermined maximum balloon sizes.